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

Model Number	36303
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
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 90 percentage of male external catheters would not stick.Patient stated that any movement would make the catheters peel off and no sense of adhesion at all (lot#jufz9068).Per additional information from cardinal health, it was reported that one in every few of the male external catheters were not sticking due to adhesive.Per sample received on 18oct2022, an additional lot was returned lot# jufz9067.Per investigator notification on (b)(6) 2022, it was reported that strong adhesive was found during sample evaluation.The affected lots were jufz9068 and jufz9067.
Event or Problem Description
It was reported that the 90 percentage of male external catheters would not stick.Patient stated that any movement would make the catheters peel off and no sense of adhesion at all (lot#: jufz9068).Per additional information from cardinal health, it was reported that one in every few of the male external catheters were not sticking due to adhesive.Per sample received on 18oct2022, an additional lot was returned lot#: jufz9067.Per investigator notification on 26oct2022, it was reported that strong adhesive was found during sample evaluation.The affected lots were jufz9068 and jufz9067.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.Although an exact root cause could not be determined a potential root cause could be mechanical failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review was not required as labelling would not have prevented the reported event.H11: section a through f - the information provided by bard 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 bard.H3 other text: the actual/suspected device was inspected.

• Brand Name: WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Common Device Name: 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: 15758552
• Report Number: 1018233-2022-08602
• Device Sequence Number: 20888140
• Product Code: NNX
• UDI-Device Identifier: 00801741071065
• UDI-Public: (01)00801741071065
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 36303
• Device Catalogue Number: 36303
• Device Lot Number: JUFZ9068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown