MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RUBBER UTILITY CATHETER

Model Number	277716
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
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.
Event or Problem Description
It was reported that the intermittent catheter was sent from the operating room that was supposed to be sterile but had a bug that was trapped inside.
Additional Manufacturer Narrative
The reported event was confirmed as supplier related.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product had caused the reported failure.Visual evaluation of the returned sample noted one unopened (with original packaging), urethral catheter.Visual inspection of the sample noted a dead bug imprinted inside the white vinyl of the sealed packaging.A potential root cause for this failure could be defective/ contaminated components from the supplier.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.Correction: h 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 intermittent catheter which was supposed to be sterile had a bug that was trapped inside.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product had caused the reported failure.Visual evaluation of the returned sample noted one unopened (with original packaging), urethral catheter.Visual inspection of the sample noted a dead bug inside the sealed packaging.A potential root cause for this failure could be defective/ contaminated components from the supplier.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 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the intermittent catheter which was supposed to be sterile had a bug that was trapped inside.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: UTILITY 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: 13307718
• Report Number: 1018233-2022-00124
• Device Sequence Number: 3386401
• Product Code: KOD
• UDI-Device Identifier: 00801741034114
• UDI-Public: (01)00801741034114
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2022

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: 01/31/2026
• Device Model Number: 277716
• Device Catalogue Number: 277716
• Device Lot Number: NGFX2339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 07/27/2022; 08/09/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 07/27/2022; 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2021
• 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