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

Model Number	0168SI18
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheters nub identified nub as part of the molded catheter, and it allowed health care professionals to see the tip of the coude foley.If patient could see the nub, then the tip would be in the upward position and would assist with correct placement of device so it would not interfere with the connections.After further review, it was noted that foley had been in place since 21sep2021.It was stated that the suspect foley material had stretched to the point it would no longer fit snuggly onto urine drainage bag connections.It was noted that the connections would not get better as the picture showed the foley was on the drainage bag connection pretty much as far as it would gone without entering the statlock space.Per additional information received with return sample on 08dec2021, it was stated that the catheter was separated from the leg bag/24-degree night drain bag and caused soling the o bed mattress and everything.It was distressing to caregiver and patient had cognitive limitation due to brain tumor.And customer asked how long a bard foley should be changed? how long 24-degree night urine collection bag be used? how long they should bard leg bag be used? how long the bard leg bag extension tube tubing be used? and customer would prefer to change these before soiling issues.Home hospital care provider said the catheter would be changed when that had problem.Also stated that, after the foley was in 2 months it still drained but leaked at the connection area.And the product was used less than the time provided, and it was leaking when connector on 24 degree leg bag and the extension tubing separated from tube.Per notification from investigator on 29jul2022, during sample evaluation it was found that the foley catheter had asymmetric balloon.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event is confirmed, manufacturing related.1 sample was confirmed to exhibit the reported failure.The product was used for treatment purposes.A potential root cause for this failure could be "operator error.Insufficient drying".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is confirmed manufacturing related, a labeling review is not required.The actual/suspected device was evaluated.
Event or Problem Description
It was reported that the foley catheters nub identified nub as part of the molded catheter, and it allowed health care professionals to see the tip of the coude foley.If patient could see the nub, then the tip would be in the upward position and would assist with correct placement of device so it would not interfere with the connections.After further review, it was noted that foley had been in place since 21sep2021.It was stated that the suspect foley material had stretched to the point it would no longer fit snuggly onto urine drainage bag connections.It was noted that the connections would not get better as the picture showed the foley was on the drainage bag connection pretty much as far as it would gone without entering the statlock space.Per additional information received with return sample on 08dec2021, it was stated that the catheter was separated from the leg bag/24-degree night drain bag and caused soling the o bed mattress and everything.It was distressing to caregiver and patient had cognitive limitation due to brain tumor.And customer asked how long a bard foley should be changed? how long 24-degree night urine collection bag be used? how long they should bard leg bag be used? how long the bard leg bag extension tube tubing be used? and customer would prefer to change these before soiling issues.Home hospital care provider said the catheter would be changed when that had problem.Also stated that, after the foley was in 2 months it still drained but leaked at the connection area.And the product was used less than the time provided, and it was leaking when connector on 24 degree leg bag and the extension tubing separated from tube.Per notification from investigator on 29jul2022, during sample evaluation it was found that the foley catheter had asymmetric balloon.

• Brand Name: BARDEX® I.C. CARSON MODEL COUDE TIP 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: 15204878
• Report Number: 1018233-2022-06269
• Device Sequence Number: 4601819
• Product Code: MJC
• UDI-Device Identifier: 00801741016974
• UDI-Public: (01)00801741016974
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 10/31/2025
• Device Model Number: 0168SI18
• Device Catalogue Number: 0168SI18
• Device Lot Number: NGFP0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2021
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: White