MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MALE EXTERNAL CATHETER; MEC

Device Problems Nonstandard Device (1420); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the adhesive of the male external catheter was too strong; making it difficult to remove.

Event Description

It was reported that the adhesive of the male external catheter was too strong; making it difficult to remove.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿too high viscosity¿.A potential root cause for this failure mode could be ¿viscometer failure or mechanical failure.¿z the lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: a labeling review is not required due to product code z635 is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the intermittent catheter labeling is found to be adequate based on past reviews.

• Brand Name: MALE EXTERNAL CATHETER
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8633287
• MDR Text Key: 145926774
• Report Number: 1018233-2019-02684
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1