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

Device Problems Difficult to Remove (1528); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the drain bag leaked on (b)(6) 2022.The patient stated that it was the third one that had leaked from near the bag outlet, and it did not leak from the outlet tubing.And stated that it seeped from where the welded circle was around the outlet tube between that circle and the bag itself.Also stated that following the patient's prostate surgery the previous year, the patient has used 2 of these bags monthly since april 2021 without leaks until dec 2021.Since then, it has been one leaky bag per month.The customer will be returning the two bags, one from march that seeped near the inlet between the large circle welded to the bag, and the other bag that began seeping from the welded circle around the outlet tube on (b)(6) 2022.And mentioned that the drain bags were the patient's nighttime choice when they did not leak.Per additional information received via phone on (b)(6) 2022, it was reported that the patient is no more experiencing any leakage from bags, but the male external catheters that the patient currently using were making the patient bleed and were painful to put on and take off.The patient had told the urologist about that issue but had not been prescribed any medication.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error.

Event Description

It was reported that the drain bag leaked on (b)(6) 2022.The patient stated that it was the third one that had leaked from near the bag outlet, and it did not leak from the outlet tubing.And stated that it seeped from where the welded circle was around the outlet tube between that circle and the bag itself.Also stated that following the patient's prostate surgery the previous year, the patient has used 2 of these bags monthly since (b)(6) 2021 without leaks until (b)(6) 2021.Since then, it has been one leaky bag per month.The customer will be returning the two bags, one from (b)(6) that seeped near the inlet between the large circle welded to the bag, and the other bag that began seeping from the welded circle around the outlet tube on (b)(6) 2022.And mentioned that the drain bags were the patient's nighttime choice when they did not leak.Per additional information received via phone on 18may2022, it was reported that the patient is no more experiencing any leakage from bags, but the male external catheters that the patient currently using were making the patient bleed and were painful to put on and take off.The patient had told the urologist about that issue but had not been prescribed any medication.

• Brand Name: MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14684456
• MDR Text Key: 300394671
• Report Number: 1018233-2022-04592
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male