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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. TEMPERATURE SENSING FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. TEMPERATURE SENSING FOLEY CATHETER Back to Search Results
Catalog Number 129414M
Device Problem Deflation Problem (1149)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 10/26/2020
Event Type  Injury  
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 deflate on the 10th day of use.The catheter was cut but water was unable to be drained.Eventually, the guidewire was inserted from the inflation lumen to burst the balloon and the catheter was removed.Per additional information received by ibc on 06nov2020, there was no impact to the patient and per additional information received by ibc on 10nov2020, it seemed that the balloon did not burst and there was no missing piece.
 
Event Description
It was reported that the catheter was difficult to deflate on the 10th day of use.The catheter was cut but water was unable to be drained.Eventually, the guidewire was inserted from the inflation lumen to burst the balloon and the catheter was removed.Per additional information received by ibc on 06nov2020, there was no impact to the patient and per additional information received by ibc on 10nov2020, it seemed that the balloon did not burst and there was no missing piece.
 
Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.A potential root cause for this failure could be due to deformed inflation eye.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use ¿ used for failure to infuse (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 ¿ used for device breakage 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: general used if there is no specific defect (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] 11) 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.".
 
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Brand Name
BARDEX I.C. TEMPERATURE SENSING FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key10874026
MDR Text Key217306137
Report Number1018233-2020-21094
Device Sequence Number1
Product Code MJC
Combination Product (y/n)N
PMA/PMN Number
K910318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number129414M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2020
Date Manufacturer Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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