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

Catalog Number	1758SI20
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
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.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.
Event or Problem Description
It was reported that the foley catheter was left in place during the surgery and was removed naturally within an hour after being left in place.There was a leakage in a balloon part.Per additional information via email from ibc on 01may2024, it was confirmed that not sure about the balloon burst.It was stated that there are none left in patient body.There was no impact to the patient.
Event or Problem Description
It was reported that the foley catheter was left in place during the surgery and was removed naturally within an hour after being left in place.There was a leakage in a balloon part.Per additional information via email from ibc on 01may2024, it was confirmed that not sure about the balloon burst.It was stated that there are none left in patient body.There was no impact to the patient.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Four photos were received for evaluation.The first two showcase an overview of the two-way catheter, evidencing that surface right under and in front of the catheter tip wet.The last two photos show the catheter cap with lot number and catheter label.Also received 1 all-silicone foley catheter.Attempted to inflate the balloon with inhouse syringe and 10 ml of methylene blue solution (3 drops 1 percentage aq methylene blue per 100ml distilled water) and lumen to lumen leak was evidenced since the solution leaked through eyelets and drainage funnel.Sample received product does not meet specifications catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.The root cause identified for capa 8266921 is: it was difficult to assure the positioning of the catheter due to vision was difficult.Dhr was not required as the capa 8266921 is applicable for this product lot number.The scope of capa 8266921 is applicable for this product lot number.Therefore, labeling review is not required.This report references a us equivalent device.The us udi equivalent for this product number is used.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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. 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: 19309799
• Report Number: 1018233-2024-02700
• Device Sequence Number: 3076680
• Product Code: EZL
• UDI-Device Identifier: 00801741025242
• UDI-Public: (01)00801741025242(11)210511(17)260510(10)NGFQ3967
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: 05/10/2026
• Device Catalogue Number: 1758SI20
• Device Lot Number: NGFQ3967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• 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: Unknown