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

Model Number	36104
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the patient was unsure in removing the male external catheter as the patient was trying to roll it down as mentioned in the instructions but it would not come off.The representative discussed with the patient if necessary to apply a warm wet compress such as a wet washcloth around the catheter to help to loosen the adhesive.It was advised to gently roll the catheter off the penis.The patient has a box of 100 and used about 40 to 50 and all of them were presented with the same issue.Also noted that they were extremely difficult to get off the plastic lid of the sombrero.The patient stated that they did not just pop off as mentioned in the instructions.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿operator error¿.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review is not required because labeling could not have prevented this issue.H11: section a through f - the information provided by bd represents all 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 or Problem Description
It was reported that the patient was unsure in removing the male external catheter as the patient was trying to roll it down as mentioned in the instructions but it would not come off.The representative discussed with the patient if necessary to apply a warm wet compress such as a wet washcloth around the catheter to help to loosen the adhesive.It was advised to gently roll the catheter off the penis.The patient has a box of 100 and used about 40 to 50 and all of them were presented with the same issue.Also noted that they were extremely difficult to get off the plastic lid of the sombrero.The patient stated that they did not just pop off as mentioned in the instructions.Per follow up via phone on 07may2021, customer stated that the instructions need to be more clear because it was difficult to understand how to remove the catheter from the sombrero.And also stated that the catheter was too sticky so it was difficult to remove from the patient after use.

• Brand Name: BARD WOVEN URETERAL CATHETER
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11801566
• Report Number: 1018233-2021-02686
• Device Sequence Number: 17315636
• Product Code: NNX
• UDI-Device Identifier: 00801741071003
• UDI-Public: (01)00801741071003
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 36104
• Device Catalogue Number: 36104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other