MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-01 for FOLEY CATHETER, 400 SERIES 8 FR 81-080408 manufactured by Deroyal Industries, Inc..
[53785252]
Investigation summary: an internal complaint (call (b)(4)) was received reporting that a foley catheter with a temperature sensor (81-080408) failed during use. The customer reported patient suffered from urine retention. This report is one of seven total filed by the reporting customer in reference to the finished good number. According to the initial complaint report, these incidents occurred over a period of several months, and the customer chose to file them at one time in a batch. No lot numbers were provided, and a sample was available for only one of the seven reported incidents. For this incident, neither a lot number nor defective sample was available. A shipping inquiry by box identification showed that four cases of finished good 81-080408 were ordered by the reporting customer in 2013 and shipped on (b)(94) 2013. The lot number shipped to the customer was 32608900, which was manufactured july 2, 2013. Review of this work order shows no discrepancies that would have contributed to the reported issue. The finished good assembly consists of the following raw materials that are assembled as detailed below: raw material part number 74-12088w (foley catheter wire supplied by (b)(4)) is received at the manufacturing plant. After receiving, a connector is molded to the wire set and a continuity test is conducted to ensure the thermistor chip has not had any affectation. The raw material is converted to part number 74-12088cr (molded foley catheter wire set) and shipped to degania silicone. Once degania silicone has received the product, the part is converted into part number 74-12089 (foley catheter 8 fr) and shipped to the plant in new tazewell for packaging. It is here the part number is converted to the finished good part number of 81-080408. The silicone catheter portion of this device is supplied by degania silicone. Therefore, a supplier corrective action request (scar) was issued to the vendor on (b)(4) 2016. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[53785253]
A patient experienced urine retention while using a foley catheter with a temperature sensor. The patient's belly was felt and found to be hard near the bladder. The patient complained of belly pain. The catheter was flushed with some resistance at first, but after that, the urine could be easily suctioned with a syringe. The catheter was ultimately replaced with a new device.
Patient Sequence No: 1, Text Type: D, B5
[62579384]
Root cause: the catheter is supplied by (b)(4), and therefore, a supplier corrective action request (scar) was issued to (b)(4). In scar response, (b)(4) stated that with the available information, it is unavailable to perform a proper investigation and define a root cause. The samples and lot number information were not provided. Corrective action: in its scar response, (b)(4) indicated a corrective action has not been taken. Investigation summary an internal complaint ((b)(4)) was received reporting that a foley catheter with a temperature sensor (81-080408) failed during use. The customer reported patient suffered from urine retention. This report is one of seven total filed by the reporting customer in reference to the finished good number. According to the initial complaint report, these incidents occurred over a period of several months, and the customer chose to file them at one time in a batch. No lot numbers were provided, and a sample was available for only one of the seven reported incidents. For this incident, neither a lot number nor defective sample was available. A shipping inquiry by box identification showed that four cases of finished good 81-080408 were ordered by the reporting customer in 2013 and shipped on july 11, 2013. The lot number shipped to the customer was 32608900, which was manufactured july 2, 2013. Review of this work order shows no discrepancies that would have contributed to the reported issue. The finished good assembly consists of the following raw materials that are assembled as detailed below: * raw material part number 74-12088w (foley catheter wire supplied by (b)(4)) is received at the manufacturing plant. After receiving, a connector is molded to the wire set and a continuity test is conducted to ensure the thermistor chip has not had any affectation. The raw material is converted to part number 74-12088cr (molded foley catheter wire set) and shipped to (b)(4). * once (b)(4) has received the product, the part is converted into part number 74-12089 (foley catheter 8 fr) and shipped to the plant in (b)(4) for packaging. It is here the part number is converted to the finished good part number of 81-080408. The two most recent work orders for raw material part 74-12088cr were reviewed and no rejects were reported during the manufacturing process. The last shipment of raw material 74-12088cr was sent to (b)(4) in 2014. Because the catheter is supplied by (b)(4), a supplier corrective action request (scar) was issued to the vendor on august 29, 2016, and a due date of october 12, 2016, was assigned. A response was not received on this date. Follow up attempts were made and a response was received november 25, 2016. The failure mode and effects analysis (fmea) was reviewed and it was determined no updates are needed at this time. Preventive action: in its scar response, (b)(4) indicated a preventive action has not been taken at this time. The investigation is complete at this time. If new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[62579405]
A patient experienced urine retention while using a foley catheter with a temperature sensor. The patient's belly was felt and found to be hard near the bladder. The patient complained of belly pain. The catheter was flushed with some resistance at first, but after that, the urine could be easily suctioned with a syringe. The catheter was ultimately replaced with a new device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2016-00016 |
| MDR Report Key | 5921436 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-01 |
| Date of Report | 2016-12-06 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-02 |
| Date Added to Maude | 2016-09-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1595 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOLEY CATHETER, 400 SERIES 8 FR |
| Generic Name | CATHETER, UPPER URINARY TRACT |
| Product Code | EYC |
| Date Received | 2016-09-01 |
| Catalog Number | 81-080408 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1595 HIGHWAY 33 SOUTH NEW TAZEWELL TN 37825 US 37825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-01 |