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

Catalog Number 01267520

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2023

Event Type  malfunction  

Event Description

It was reported that foley catheter had leakage from pipe wall.

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 Description

It was reported that foley catheter had leakage from pipe wall.

Manufacturer Narrative

The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used foley catheter.Visual inspection of the sample noted attempted to inflate the catheter balloon and leak observed from a pin hole (measuring 0.013') 1.3120" from the trifurcation.This does not meet specification which states "cap/valve must not leak, and no holes are allowed in the balloon or catheter surface".A potential root cause for this failure mode could be ¿imperfection in balloon due to process".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: "storage: do not store at extreme temperatures.Caution: this product contains natural rubber latex which may cause allergic reactions".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 actual/suspected device was inspected.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER CREEVY MODEL
• Type of Device: 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: 18329040
• MDR Text Key: 330967869
• Report Number: 1018233-2023-08937
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741018800
• UDI-Public: (01)00801741018800
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K910195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 01267520
• Device Lot Number: NGGS2572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other