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

Model Number 0165SI16

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Leak/Splash (1354); No Flow (2991)

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

Event Date 06/30/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that urine leaked from the meatus along the catheter and the urine flow disappeared.Subsequently, an attempt to deflate the catheter was done, however it was difficult to deflate the balloon.The cathter was pulled out of the patient and replaced.It was later reported to (b)(6) (international business center representative), that the difficulty to deflate happened twice on the patient.The catheter was placed on (b)(6) 2018.The catheter was replaced with another one on (b)(6) 2018.Additionally, due to the difficulty to deflate, the catheter¿s shaft was cut.The catheter was placed on (b)(6) 2018 and was difficult to deflate on (b)(6) 2018.The catheter was pulled in order to be removed.

Event Description

It was reported that urine leaked from the meatus along the catheter and the urine flow disappeared.Subsequently, an attempt to deflate the catheter was done, however it was difficult to deflate the balloon.The cathter was pulled out of the patient and replaced.It was later reported to takuma tsuji (international business center representative), that the difficulty to deflate happened twice on the patient.The catheter was placed on 6/20/2018.The catheter was replaced with another one on 6/26/2018.Additionally, due to the difficulty to deflate, the catheter¿s shaft was cut.The catheter was placed on 6/26/2018 and was difficult to deflate on 6/30/2018.The catheter was pulled in order to be removed.

Manufacturer Narrative

The reported event was found inconclusive due to the way the sample was received.Per evaluation, heavy salt accumulation was noted inside of the drainage lumen causing the urine blockage which made it difficult for water to flow through the catheter.Based on evaluation, the sample was classified as poor sample condition and several inspections could not been carried out.The exact time of how and when problem occurred could not be determined.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "(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 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) patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter".

• 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: 7715242
• MDR Text Key: 115190555
• Report Number: 1018233-2018-02998
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016752
• UDI-Public: (01)00801741016752
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 0165SI16
• Device Catalogue Number: 0165SI16
• Device Lot Number: 8AG0121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR