MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-05 for FOLEY CATHETER WITH TEMPERATURE SENSOR 81-080408 manufactured by Deroyal Industries, Inc..
[90152446]
Investigation summary: an internal complaint (call (b)(4)) was received indicating that a wire was found protruding from a foley catheter near the external collection bag. Prior to this, the device was not reading a temperature. A sample was reported to be available and is expected to be returned. However, as of the date of this report, it has not been received. The work order was reviewed for discrepancies that may have contributed to the reported event. The work order showed that one catheter was rejected. However, this was due to the catheter being dirty, not for a protruding wire. The raw material and finished good inventory was checked. No non-conforming product was found. The catheter portion of the device is manufactured by (b)(4). Therefore, a supplier corrective action request (scar) was issued september 12, 2017, to (b)(4). A response is due october 25, 2017. As of the date of this report, that response has not been received. 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
[90152447]
A wire was protruding from the foley catheter with temperature sensor where it would connect to the external collection bag. Prior to this, the temperature was no longer reading when connected to the monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2017-00012 |
| MDR Report Key | 6916675 |
| Date Received | 2017-10-05 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-10-05 |
| 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 | 0 |
| Brand Name | FOLEY CATHETER WITH TEMPERATURE SENSOR |
| Generic Name | CATHETER, UPPER URINARY TRACT |
| Product Code | EYC |
| Date Received | 2017-10-05 |
| Returned To Mfg | 2017-10-09 |
| Model Number | 81-080408 |
| Lot Number | 43865531 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-05 |