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

Model Number	36101
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the male external catheter slips off because it was not adhesive enough.Stated that the catheter appeared thinner.Also stated that the customer received the order from byram 30 days ago, but the catheter had an expiration date of 12/20/2016.Per follow up via phone on (b)(6) 2022, it was reported that the situation has not been resolved.Patient confined to a wheelchair since partially paralyzed.Patient could not move around at night when in bed and woke up one morning completely drenched in urine.This has occurred while they use wheelchair too.Stated that the catheters appear defective right out of the box.Customer provided two catalog numbers were pcn-36101 with lot# jugn9178- and pcn-36301-provided through byram healthcare.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "wrong label put on package".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.Correction: h.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.
Event or Problem Description
It was reported that the male external catheter slips off because it was not adhesive enough.Stated that the catheter appeared thinner.Also stated that the customer received the order from byram 30 days ago, but the catheter had an expiration date of 12/20/2016.Per follow up via phone on 26jul2022, it was reported that the situation has not been resolved.Patient confined to a wheelchair since partially paralyzed.Patient could not move around at night when in bed and woke up one morning completely drenched in urine.This has occurred while they use wheelchair too.Stated that the catheters appear defective right out of the box.Customer provided two catalog numbers were pcn-36101 with lot# jugn9178- and pcn-36301-provided through byram healthcare.

• 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: 15166713
• Report Number: 1018233-2022-06065
• Device Sequence Number: 16671522
• Product Code: NNX
• UDI-Device Identifier: 00801741070976
• UDI-Public: (01)00801741070976
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 09/01/2022

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: 36101
• Device Catalogue Number: 36101
• Device Lot Number: JUGN9178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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: Male