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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); Material Twisted/Bent (2981); No Flow (2991)
Patient Problems Urinary Retention (2119); Patient Problem/Medical Problem (2688)
Event Date 11/13/2019
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 there was no urine flow observed.This continued for 1 hour, then the user tried to remove the catheter for replacement, and found the balloon was difficult to deflate.An echo and ct scan were done and confirmed that the balloon part of the catheter was bent and placed.The user then cut the inflation lumen but no water would come out.A guidewire was inserted in to the inflation lumen, the balloon then deflated and the catheter was removed.Per additional information received via email on 9 december 2019 from ibc representative, the guidewire was used to deflate the balloon.There were no missing pieces of the balloon.
 
Event Description
It was reported that there was no urine flow observed.This continued for 1 hour, then the user tried to remove the catheter for replacement, and found the balloon was difficult to deflate.An echo and ct scan were done and confirmed that the balloon part of the catheter was bent and placed.The user then cut the inflation lumen but no water would come out.A guidewire was inserted in to the inflation lumen, the balloon then deflated and the catheter was removed.Per additional information received via email on 9 december 2019 from ibc representative, the guidewire was used to deflate the balloon.There were no missing pieces of the balloon.
 
Manufacturer Narrative
The reported issue was unconfirmed.The device was returned and visually inspected.Sample was evaluated and observed that there was no bent on the returned sample.Dissected the catheter and found no conditions that would contribute to the reported event.The exact cause on how and when the problem occurred could not be determine.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: ¿[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 (1) 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) 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.] (4) 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.
 
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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 Key9489432
MDR Text Key178622589
Report Number1018233-2019-08051
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 01/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
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 Manufacturer12/16/2019
Date Manufacturer Received12/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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