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

Model Number 0165SI16

Device Problem Failure to Infuse (2340)

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

Event Date 01/29/2021

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 catheter was difficult to inflate during pretest.

Event Description

It was reported that the catheter was difficult to inflate during the pretest.

Manufacturer Narrative

The reported event was unconfirmed as the product meet the specifications.Visual inspection of the exterior of the sample did not found any evidence of a failure that would support the reported event.The catheter balloon was inflated with 10 ml of water using normal fill technique and the balloon inflated without difficulty in 16 seconds and the inflation funnel did not balloon out during the inflation.The catheter balloon was deflated and reinflated again the balloon with quick fill technique and the balloon inflated without difficulty in 9 seconds and the inflation funnel did not balloon out during the inflation.The catheter was dissected and did not found anything to contribute to the reported problem.The product did not caused the reported failure.A potential root cause for this failure mode could be due to a thin rubberize wall which caused the collapse or pinch inflation lumen under the balloon or along the shaft.However this could not be confirmed.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 or urethra may be injured.] 2.Applicable patients 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 percent 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." 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 I.C. 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: 11379342
• MDR Text Key: 233536934
• Report Number: 1018233-2021-00822
• 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): Y
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: 0165SI16
• Device Catalogue Number: 0165SI16
• Device Lot Number: 0NG032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other