MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® URETHRAL CATHETER ROBINSON MODEL

Model Number	056110
Medical Device Problem Codes	Flaked (1246); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the robinson intermittent catheter packaging was flaked off onto other components inside the pack.The provided lots were (ngdz3241), (ngez0776), (ngfn2700).
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 robinson intermittent catheter packaging was flaked off onto other components inside the pack.The provided lots were (ngdz3241), (ngez0776), (ngfn2700).
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The product had caused the reported failure.Visual evaluation of the attached photo sample noted 1 unopened (with original packaging), ureteral catheter.Visual inspection of the sample noted flacking of the strip packaging inside the sealed packaging on the catheter.This is out of specification, which states "loose foreign matter, engraved and spots >1/32¿ is not allowed".A potential root cause for this could be not following the production areas cleaning procedure.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 labeling could not have prevented the reported failure.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.

• Brand Name: BARDEX® URETHRAL CATHETER ROBINSON MODEL
• Common Device Name: URETHRAL 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: 13259729
• Report Number: 1018233-2022-00035
• Device Sequence Number: 16569266
• Product Code: KOD
• UDI-Device Identifier: 00801741033506
• UDI-Public: (01)00801741033506
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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 Expiration Date: 01/31/2025
• Device Model Number: 056110
• Device Catalogue Number: 056110
• Device Lot Number: NGFN2700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/01/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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