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

Model Number	32302
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
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.The information provided by bd represents all of the known information at this time.
Event or Problem Description
It was reported that the product expiration date differed from the best-before date on the carton/label.
Additional Manufacturer Narrative
The reported event is confirmed- manufacturing related.Visual evaluation 2 photo samples received attached in nonconformance report both showing external packaging of product.One picture shows the package label of mec stating the expiration date as july 21, 2026 and the second picture received shows package label of box of mecs stating the expiration date as july 28, 2026.Based on the different dates printed onto the products the product does not meet specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labelling review is not required as it would not have prevented the reported event.Correction: g 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.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the product expiration date differed from the best-before date on the carton/label.

• 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: 14397626
• Report Number: 1018233-2022-03710
• Device Sequence Number: 12093686
• Product Code: NNX
• UDI-Device Identifier: 00801741070549
• UDI-Public: (01)00801741070549
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: Health Professional
• Device Expiration Date: 07/28/2026
• Device Model Number: 32302
• Device Catalogue Number: 32302
• Device Lot Number: JUFV9017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2021
• 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: Male