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

Model Number	73022L
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
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 there was a hole just distal to the three-way port of the foley catheter, so the irrigants were squirting out.Stated that the sample was not available since it was with the patient, and it was discarded.Per follow up via email received on 03-feb-2023, it was stated that they had three incidents at the hospital where 22french silicon 3 ways catheters were placed.Once the cbi was started it was noticed that water was gushing out of the sides due to a hole.In terms of impact, the hole in the catheter would break sterility.It was also stated that it was painful for patients to have catheters replaced especially one as large as a 22french catheters.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿silicone too weak to withstand normal forces applied during use".It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: ifu states "visually inspect the product for any imperfections or surface deterioration prior to use." 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 device was not returned.
Event or Problem Description
It was reported that there was a hole just distal to the three-way port of the foley catheter, so the irrigants were squirting out.Stated that the sample was not available since it was with the patient, and it was discarded.As per follow up via email received on 03feb2023, it was stated that they had three incidents at the hospital where 22french silicon 3 ways catheters were placed.Once the cbi was started it was noticed that water was gushing out of the sides due to a hole.In terms of impact, the hole in the catheter would break sterility.It was also stated that it was painful for patients to have catheters replaced especially one as large as a 22french catheters.As per additional information received via email on 03mar2023, it was reported that the another catheter with a hole was found today.They currently had 8 and a half boxes full of 22fr silicon 3 way catheters and they were no longer feel comfortable using these catheters.The hole was small and on the third port section of the tube and very distal and just proximal to the bifurcation.We only see the hole once the cbi irrigant was turned on and it squirts out.In terms of patient care, exchanging the catheter was painful and increases their risk of developing a urinary tract infection.No medical intervention was reported.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE 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: 16363433
• Report Number: 1018233-2023-00815
• Device Sequence Number: 6813613
• Product Code: EZL
• UDI-Device Identifier: 00801741034329
• UDI-Public: (01)00801741034329
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070558
• 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): 04/06/2023

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: 08/30/2025
• Device Model Number: 73022L
• Device Catalogue Number: 73022L
• Device Lot Number: NGGV1850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2022
• 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: Other
• Patient Sex: Unknown