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

Model Number 0165SI14

Device Problems Deflation Problem (1149); Difficult to Remove (1528); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

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 there was no urine flow at all after the catheter placement on the day of use.The user attempted to inject water from the drainage lumen, but failed.It was further reported that the catheter balloon was difficult to be deflated when being replaced with another catheter.The catheter was cut near the inflation valve, and the water was able to be aspirated from the inflation lumen.

Manufacturer Narrative

The reported event was inconclusive due to the poor sample condition.The sample was evaluated and no pinch or blockage was observed.Water was able to be introduced in all returned catheters.Due to the poor condition of the returned sample, a complete evaluation could not be performed.A potential root cause for this failure mode could be user related due to heavy salt accumulation on drainage eye causing blockage.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: "[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) patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter [directions for use] (10) to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered.2.Precautions for use (1) when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.(2) when deflating balloon, do not aspirate with a syringe.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.]".

Event Description

It was reported that there was no urine flow at all after the catheter placement on the day of use.The user attempted to inject water from the drainage lumen, but failed.It was further reported that the catheter balloon was difficult to be deflated when being replaced with another catheter.The catheter was cut near the inflation valve, and the water was able to be aspirated from the inflation lumen.

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9935032
• MDR Text Key: 187532583
• Report Number: 1018233-2020-02430
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Device Lot Number: 9ML005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1