MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-29 for FOLEY CATHETER, 400 SERIES 8 FRENCH 81-080408 manufactured by Degania Medical Devices Pvt. Ltd..
[129326727]
Root cause: the device is manufactured for (b)(4) by (b)(4). A photograph of the defective device was sent to (b)(4) for evaluation, and the manufacturer determined that the root cause was the result of use error. Corrective action: due to the root cause determination, a corrective action has not been taken. Investigation summary: an internal complaint (b)(4) was received for a foley catheter (finished good 81-080408, lot not provided) that contained a temperature probe wire that was protruding from the device. The device history record could not be reviewed because the lot number was not reported. Raw material and finished good inventory were checked and no non-conforming product was found. A sample was received from the customer for evaluation. Photos of the defective device were taken and sent to the manufacturer, (b)(4), for evaluation. The vendor determined that the catheter was pulled strongly, stretching the silicone shaft and thermocouple wire, which caused the deformation. A supplier corrective action request was issued to (b)(4). A response has been received. 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
[129326728]
The temperature probe wires were protruding from the catheter, which placed the patient at risk for significant urethral injury. The catheter was removed and replaced, and there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320762-2018-00012 |
| MDR Report Key | 8116868 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-10-22 |
| Date Mfgr Received | 2018-10-30 |
| Date Added to Maude | 2018-11-29 |
| 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, 400 SERIES 8 FRENCH |
| Generic Name | CATHETER, UPPER URINARY TRACT |
| Product Code | EYC |
| Date Received | 2018-11-29 |
| Returned To Mfg | 2018-11-07 |
| Model Number | 81-080408 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEGANIA MEDICAL DEVICES PVT. LTD. |
| Manufacturer Address | 275 & 251 SEC-6 IMT MANESAR GURGAON, HARYANA 122050 IN 122050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-29 |