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

Model Number	056110
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the loose particulates was coming off from the packaging of robinson intermittent catheters.Per additional information received via email on 10jan2022, it was reported that the loose particulates were found by the medline production team.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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 loose particulates was coming off from the packaging of robinson intermittent catheters.Per additional information received via email on 10jan2022, it was reported that the loose particulates were found by the medline production team.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.3 out of the 11 samples and 3 out of the 48 samples were confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted 11 unopened (with original packaging), urethral catheters and 48 additional urethral catheters samples.Visual inspection of the sample noted flaking of the strip outside packaging when touching the packaging, flaking on the gloves and table.Additionally tested 3 out of the 11 samples and 3 out of the 48 samples and flaking immediately occurred when touching packing.Also noted no flaking was observed on the inside of the sealed packaging on the catheter.This is out of specification per inspection procedure, which states "loose foreign matter, engraved and spots >1/32¿ is not allowed".A potential root cause for this failure mode could be ¿inadequate assembly process.Stress on materials during shipment and handling¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the loose particulates was coming off from the packaging of robinson intermittent catheters.Per additional information received via email on 10jan2022, it was reported that the loose particulates were found by the medline production team.

• 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: 13290586
• Report Number: 1018233-2022-00103
• Device Sequence Number: 11943951
• Product Code: KOD
• UDI-Device Identifier: 00801741033506
• UDI-Public: (01)00801741033506
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

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: 07/31/2026
• Device Model Number: 056110
• Device Catalogue Number: 056110
• Device Lot Number: NGFW2958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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