MAUDE Adverse Event Report: INTEGRA - MILTEX FEMALE CATHETR 5-3/4 14FR; M18 - UROLOGY

Catalog Number 29-32-14

Device Problems Defective Device (2588); Device Unsafe to Use in Environment (2918); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Retention (2119); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.".

Manufacturer Narrative

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.

Manufacturer Narrative

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.

• Brand Name: FEMALE CATHETR 5-3/4 14FR
• Type of Device: M18 - UROLOGY
• Manufacturer (Section D): INTEGRA - MILTEX; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA - MILTEX; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6477488
• MDR Text Key: 72292722
• Report Number: 2523190-2017-00046
• Device Sequence Number: 1
• Product Code: FBX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 29-32-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR