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

Catalog Number 0119L18

Device Problem Decrease in Pressure (1490)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the water leaked from the foley catheter during a pretest.Per follow up on 19oct2020, there was no visible damage to the foley catheter.

Event Description

It was reported that the water leaked from the foley catheter during a pretest.Per follow up on 19oct2020, there was no visible damage to the foley catheter.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.The root cause of this failure mode is could be "manufacturing related due to operator error/ mechanical error/ thin rubberized layer/poor stripping".The device history record was reviewed and found a possible manufacturing issue that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "method for use: (1) do not inflate the balloon in the urethra.(the urethra may be injured) (2) do not pull the catheter hard.(the bladder/urethra maybe injured) 2.Applicable patients (1) patients with delirium who might pull out catheter (when patient tugs at catheter unconsciously, the bladder and urethra may be damaged).Contraindications 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) do not use on patients who are or have been allergic to natural rubber latex." corrections: d, h.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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10755871
• MDR Text Key: 213687323
• Report Number: 1018233-2020-20555
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 0119L18
• Device Lot Number: MYER1831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other