MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 POP-ON SELF-ADHERING MALE EXTERNAL CATHETER

Catalog Number 32301

Device Problems Leak/Splash (1354); Nonstandard Device (1420)

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 male external catheter had strong adhesive and caused leakage.

Event Description

It was reported that the male external catheter had strong adhesive and caused leakage.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿viscometer failure or mechanical failure.¿ it was unknown whether the device had met specifications.The product used for the treatment but it was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "instructions for silicone self-adhesive sheath.Note: do not use on irritated or compromised skin.Do not use if allergic reaction occurs.If sheath has an insert, remove it.Not made with natural rubber latex.".

• Brand Name: POP-ON SELF-ADHERING MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10403507
• MDR Text Key: 203522321
• Report Number: 1018233-2020-05153
• 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: distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 32301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1