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

Catalog Number 0165L14

Device Problem Decrease in Pressure (1490)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2020

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 during a pretest, water leaked from near the balloon of the foley catheter.As per the follow-up received via ibc on 13oct2020, there was no visible damage to the returned sample.

Event Description

It was reported that during a pretest, water leaked from near the balloon of the foley catheter.As per the follow-up received via ibc on 13oct2020, there was no visible damage to the returned sample.

Manufacturer Narrative

The reported event was unconfirmed since the problem could not be reproduced.No root cause could be found because the reported event was unconfirmed.Visual inspection noted the exterior of the sample and did not find any evidence of a failure that would support the reported event.Functional testing was performed by inflating with air while submerged in water and noted no air bubbles leaking from the catheter.Inflated with 10ml of water and performed leak test.On the seventh day, the balloon was fully inflated with no signs of leaking.Dissected and inspected rubberize layer and confirmed no leakage along the rubberize layer of the lumen.The returned sample met specification.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: "[warnings] 1.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 may be 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) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) 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.] (5) 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 in patients who are or have been allergic to natural rubber latex." correction: 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.The actual/suspected device was inspected.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10752116
• MDR Text Key: 213685633
• Report Number: 1018233-2020-20538
• 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: 01/27/2021

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 Expiration Date: 01/28/2023
• Device Catalogue Number: 0165L14
• Device Lot Number: MYDZ2928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other