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

Catalog Number 129414M

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 01/31/2020

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 it was difficult to deflate on the 9th day of use.No patient injury reported.2cc water was left in the balloon.The fragment of the catheter was left in the body due to the breakage.The catheter was pulled out and it was removed.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.The evaluation found that the returned catheter could not be deflated due to a poorly snip eye.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: do not inflate the balloon in the urethra.[the urethra may be injured.].Do not pull the catheter hard.[the bladder/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.].[contradictions].1.Method for use: do not reuse.Do not resterilize.This device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.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.] 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: do not use in patients who are or have been allergic to natural rubber latex.[directions for use].Method of use: the device is intended for single use only and is not reusable.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." 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.

Event Description

It was reported that it was difficult to deflate on the 9th day of use.No patient injury reported.2cc water was left in the balloon.The fragment of the catheter was left in the body due to the breakage.The catheter was pulled out and it was removed.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9794339
• MDR Text Key: 185053351
• Report Number: 1018233-2020-01569
• Device Sequence Number: 1
• Product Code: MJC
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 129414M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1