MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2017-04-10 for FEMALE CATHETR 5-3/4 14FR 29-32-14 manufactured by Integra - Miltex.
[72292722]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[72292723]
Dealer initially reports stripping of flesh. On 4/3/2017 patient reports "the new (urethral) catheters were manufactured differently & have sharp edges which has taken small pieces of flesh after my bladder has been empty upon removal. "
Patient Sequence No: 1, Text Type: D, B5
[73578339]
On 04/10/2017 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - pictures provided by the customer, stating that the catheters are sharp and are stripping off flesh. Upon further investigation, a 1. 5aql was performed on existing inventory; it is found that none of the catheters have sharp edges. According to the attached pictures provided by the end user, we are unable to detect product markings and product id; therefore the complaint is unconfirmed. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: none. Corrective action preventive action history/corrections: none. Health hazard evaluation history: none. Conclusion: there were pictures of the non-conforming catheters provided by the end user and the complaint report stating that they are stripping off flesh. According to the attached pictures provided by the end user, we are unable to detect product markings and product id; therefore the complaint is unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
[109939772]
On 5/31/2017 integra investigation completed. Device history evaluation - there were nine female catheter returned 4 out of the nine was damaged/sharped. The complaint report has been confirmed; the root cause has been identified as a workmanship or material deficiency. Appropriate action has been implemented to rectify this manufacturing deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2017-00046 |
| MDR Report Key | 6477488 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2017-04-10 |
| Date of Report | 2017-03-27 |
| Date Mfgr Received | 2017-05-31 |
| Device Manufacturer Date | 2016-09-01 |
| Date Added to Maude | 2017-04-10 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA - MILTEX |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEMALE CATHETR 5-3/4 14FR |
| Generic Name | M18 - UROLOGY |
| Product Code | FBX |
| Date Received | 2017-04-10 |
| Returned To Mfg | 2017-05-19 |
| Catalog Number | 29-32-14 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA - MILTEX |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-10 |