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

Device Problem Biocompatibility (2886)

Patient Problems Pain (1994); Injury (2348); Skin Tears (2516); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2021

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 there was an issue with the surestep male external catheter starter kit meter.Per follow up received via mail on 29jan2021, the device created a skin tear on the penises of 2 different patients.The patient experienced pain as a result of skin tear, and also injury was noted after removal.No medical intervention was reported.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that there was an issue with the surestep male external catheter starter kit meter.Additional information required.Per follow up received via email on 29jan2021 the device created a skin tear on the penis of 2 different patients.The patient experienced pain as a result of skin tear and also injury was noted after removal.No medical intervention was reported.Per additional information received via email on 25feb2021 another patient had developed wounds from the bard male external catheter.The patient was noticed with open wounds on the dorsal and ventral aspects of the penis.No medical intervention reported.Also the surestep male external catheter (the actual catheter component) is the same as the spirit condom catheter did not change and contain additional or any different adhesives than before.

• 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
• MDR Report Key: 11343202
• MDR Text Key: 232369861
• Report Number: 1018233-2021-00611
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other