MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-06-29 for FOLEY CATHETER WITH TEMPERATURE SENSOR BS81-080410 manufactured by Deroyal Cientifica De Latinoamerica S.r.l..
[112851743]
Investigation summary. An internal complaint (b)(4) was received indicating a foley catheter with temperature sensor (part (b)(4)) failed during use. The end user was unable to remove water from the catheter balloon prior to device removal, resulting in some bleeding and discomfort to patients. The defective sample was discarded and unable to be returned for evaluation. A review of the device history record showed no discrepancies that may have contributed to the reported problem. Raw material and finished good stock of the same lot reported on the call was tested at the manufacturing facility. Testing was performed by filling the catheter balloon with saline and removing it. All balloons inflated and deflated with no issues. The silicone portion of the catheter is manufactured by degania silicone. Therefore, a supplier corrective action request was issued to degania on (b)(6) 2018. As of the date of this report, a response has not been received. Finished good samples from the same lot reported on the call were shipped to the vendor (b)(6) 2018, for additional testing. 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
[112851744]
The nursing staff inserted the catheter, and 3mls of water were inserted into the balloon. Staff was unable to remove water prior to removal. The balloon had to be deflated after piercing with wire. Two instances of this were reported. In one instance, the end user stated the event caused bleeding when the device was removed without being deflated. In the other instance, the patient experience discomfort and leapt from the bed. The staff inserted a guidewire to deflate the device and it was removed without further intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2018-00004 |
| MDR Report Key | 7652476 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-06-29 |
| Date of Report | 2018-08-13 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-05-31 |
| Date Added to Maude | 2018-06-29 |
| 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 WITH TEMPERATURE SENSOR |
| Generic Name | CATHETER, UPPER URINARY TRACT |
| Product Code | EYC |
| Date Received | 2018-06-29 |
| Model Number | BS81-080410 |
| Lot Number | 44325472 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. |
| Manufacturer Address | GLOBAL PARK BOX 180-3006, 602 PARKWAY LA AURORA, HEREDIA, HEREDIA 146 CS 146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-29 |