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

Model Number	7323
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had noticed a change in the packaging of their sheath.The white plastic was a lot thinner and on the clear plastic side it was very thin and vacuum was packed around the sheath.They also felt that the sheath itself was inferior to what they had been using with and were coming off more frequently.As per sample evaluation results received on (b)(6) 2022, stated that the strong adhesive was found during sample evaluation.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
Upon further review, bd has determined that there was no allegation against product.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.
Event or Problem Description
It was reported that the patient had noticed a change in the packaging of their sheath.The white plastic was a lot thinner and on the clear plastic side it was very thin and vacuum was packed around the sheath.They also felt that the sheath itself was inferior to what they had been using with and were coming off more frequently.As per sample evaluation results received on 07-dec-2022, stated that the strong adhesive was found during sample evaluation.Per investigator notification received on 03jan2023, stated that the tested sample was within specification and no strong adhesive was found.

• Brand Name: POP-ON¿ 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: 16052462
• Report Number: 1018233-2022-09854
• Device Sequence Number: 20397595
• Product Code: NNX
• UDI-Device Identifier: 00801741071652
• UDI-Public: (01)00801741071652
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 7323
• Device Catalogue Number: 32303
• Device Lot Number: JUGS9026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 01/04/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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