MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

Catalog Number	802516
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intermittent catheter did not have an outer coating causing friction when inserted and the hole was too large causing the catheter to flex when going inside the bladder.Per customer follow up received on 02apr2024, it was reported that there were two lots affected.There was no patient impact.Per additional information received on 02apr2024, the one on the right has no outer coating so it did not slide smoothly and causes friction.The hole was too large and caused the catheter to flex when going into the bladder.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 intermittent catheter did not have an outer coating causing friction (lot#nghv1844), (lot#nghx3849) when inserted and the hole was too large causing the catheter to flex when going in the bladder.Per customer follow up received on 02apr2024, it was reported that there were two lots affected.There was no patient impact.(lot#nghv1844) (lot#nghx3849).Per additional information received on 02apr2024, the one on the right has no outer coating so it did not slide smoothly and causes friction.The hole was too large and caused the catheter to flex when going into the bladder.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be " over dried due to operator error." however, there was insufficient information to confirm this potential root cause.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labeling could not have prevented the reported failure.Correction: d.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.

• Brand Name: BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER
• Common Device Name: FOLEY 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19049506
• Report Number: 1018233-2024-01875
• Device Sequence Number: 12902947
• Product Code: KOD
• UDI-Device Identifier: 00801741039058
• UDI-Public: (01)00801741039058
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/15/2024

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 Catalogue Number: 802516
• Device Lot Number: NGHV1844
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2023
• 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