MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER; LUBRISIL 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	05/27/2021
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.The device was not returned.
Event or Problem Description
It was reported that the balloon was inflated and a stream of water squirted out from a previously unrecognizable tiny hole in the catheter, approximately 3cm from where the balloon channel exits the catheter.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "damage core pin or insert / hit insert against the mold or the table".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.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: "visually inspect the product for any imperfections or surface deterioration prior to use".Additionally, it also states "recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 15cc balloon: use 20ml sterile water 20cc balloon: use 25ml sterile water 30cc balloon: use 35ml sterile water 40cc balloon: use 45ml sterile water 75cc balloon: use 80ml sterile water do not exceed recommended capacities".It also states "warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter".H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that the balloon was inflated and a stream of water squirted out from a previously unrecognizable tiny hole in the catheter, approximately 3cm from where the balloon channel exits the catheter.It was reported that bard lubrisil foley catheter was placed on male patient who had a transurethral resection of the prostate with the lase and the doctor inflated the balloon a stream of water squirted out from a previously unrecognizable tiny hole in the catheter approximately 3 centi meter from where the balloon channel exit the catheter.Also stated that same situation was occurred in previous week and the hole was in the exact same spot on that catheter.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Common Device Name: LUBRISIL FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12107722
• Report Number: 1018233-2021-03994
• Device Sequence Number: 19724157
• Product Code: EZL
• UDI-Device Identifier: 00801741034329
• UDI-Public: (01)00801741034329
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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 Expiration Date: 01/31/2025
• Device Model Number: 73022L
• Device Catalogue Number: 73022L
• Device Lot Number: NGET2555
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other