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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; FOLEY CATHETER (LATEX)
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER; FOLEY CATHETER (LATEX) Back to Search Results
Catalog Number 129414M
Device Problems Deflation Problem (1149); Inflation Problem (1310); Failure to Infuse (2340); No Flow (2991); Physical Resistance/Sticking (4012)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/11/2020
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 the catheter balloon was difficult to inflate, and the user felt resistance during infusion while placing the catheter in the patient.It was further reported that the catheter was also difficult to deflate, and the user tried passively removing the water but it would not come out.The catheter was pulled from the patient's body with the balloon filled.Per additional information from the ibc via email 22mar2020, there was no medical intervention required for the removal of the inflated balloon.
 
Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.Evaluation found catheter can be inflated without difficulty.Dissected the catheter and found no conditions that would contribute to the reported problem.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/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% 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.
 
Event Description
It was reported that the catheter balloon was difficult to inflate, and the user felt resistance during infusion while placing the catheter in the patient.It was further reported that the catheter was also difficult to deflate, and the user tried passively removing the water but it would not come out.The catheter was pulled from the patient's body with the balloon filled.Per additional information from the ibc via email 22mar2020, there was no medical intervention required for the removal of the inflated balloon.
 
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Brand Name
BARDEX® I.C. TEMPERATURE SENSING 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 Key9922642
MDR Text Key187266972
Report Number1018233-2020-02341
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 distributor,other
Type of Report Initial,Followup
Report Date 06/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/28/2022
Device Catalogue Number129414M
Device Lot Number9KS152
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2020
Date Manufacturer Received05/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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