MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER

Model Number	0166SI18
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter balloon ruptured about 45 minutes after insertion.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It was unknown whether the device had met relevant specifications.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be for this failure mode could be ¿short latex dwell time" or "latex dip speed out too slow" and also might be contributed by user related (example: contact with sharp object/ exposure to petrolatum based products mechanical failure/operator error).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿cdc guidelines for appropriate indications for indwelling urethral catheter use patient has acute urinary retention or bladder outlet obstruction; need for accurate urine output measurements; use for selected surgical procedures; to assist in healing of open sacral or perineal wounds; patient requires prolonged immobilization; to improve comfort for end of life care.Proper techniques for urinary catheter insertion: perform hand hygiene immediately before and after insertion; insert urinary catheters using aseptic technique and sterile equipment; use the smallest foley catheter possible, consistent with good drainage; document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record.Proper techniques for urinary catheter maintenance: secure the foley catheter.Use the statlock® foley stabilization device if provided.Maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions.Maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.Keep the collection bag below the level of the bladder or hips at all times.Empty the collection bag regularly using a separate.¿.

• Brand Name: BARDEX® I.C. 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14166471
• Report Number: 1018233-2022-02757
• Device Sequence Number: 5025182
• Product Code: MJC
• UDI-Device Identifier: 00801741016851
• UDI-Public: (01)00801741016851
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• 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
• Report Date (Section B): 03/30/2022

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: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: 0166SI18
• Device Catalogue Number: 0166SI18
• Device Lot Number: NGFT2260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• 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: Female