MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

Model Number	772415
Medical Device Problem Codes	Material Fragmentation (1261); Component Misassembled (4004)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
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 in and out cath being done on labor patient with epidural to empty bladder.Nursing staff stated that the intermittent catheter was intact when inserted into urethra but came out missing the top portion.It was stated that the patient ended up having to under cystostomy after delivery.As per investigator notification on 06jul2022, it was stated that an additional red rubber catheter was returned for sample evaluation.
Additional Manufacturer Narrative
The reported event is confirmed, manufacturing related.One red rubber catheter was returned without the original packaging.The length of the shaft was visually inspected and no lumps, discoloration, or anomalies were noted.Some flashing appeared to be present within the drainage eye.A potential root cause for this event could be, "operator error, dull punch dies" or "machine error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as a review of the label could not have prevented the reported event.Corrections: d,f,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 evaluated.
Event or Problem Description
It was reported that in and out cath being done on labor patient with epidural to empty bladder.Nursing staff stated that the intermittent catheter was intact when inserted into urethra but came out missing the top portion.It was stated that the patient ended up having to under cystostomy after delivery.As per investigator notification on (b)(6) 2022, it was stated that an additional red rubber catheter was returned for sample evaluation.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: TRAY WITH RED RUBBER 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: 15079770
• Report Number: 1018233-2022-05676
• Device Sequence Number: 17346904
• Product Code: KOD
• UDI-Device Identifier: 00801741030413
• UDI-Public: (01)00801741030413
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 772415
• Device Catalogue Number: 772415
• Device Lot Number: NGGN4134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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: Required Intervention
• Patient Sex: Unknown