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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. FOLEY CATHETER; FOLEY CATHETER (LATEX)
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER; FOLEY CATHETER (LATEX) Back to Search Results
Model Number 0165SI18
Device Problems Deflation Problem (1149); Inaccurate Flow Rate (1249); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2018
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 the balloon of the catheter on the day of placement.The user cut the shaft and tried to deflate the balloon by pumping, but only 2-3 ml of water came out.The user inserted a guidewire into the inflation lumen, but no water came out.Finally, the balloon was punctured percutaneously, and the catheter was removed.It was later reported that there was no urine flow after the catheter was placed.Allegedly, this is why the user decided to replace the catheter.
 
Event Description
It was reported that it was difficult to deflate the balloon of the catheter on the day of placement.The user cut the shaft and tried to deflate the balloon by pumping, but only 2-3 ml of water came out.The user inserted a guidewire into the inflation lumen, but no water came out.Finally, the balloon was punctured percutaneously, and the catheter was removed.It was later reported that there was no urine flow after the catheter was placed.Allegedly, this is why the user decided to replace the catheter.
 
Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.Received only catheter cut into 3 pieces at the inflation funnel and also bifurcation area.The sample was evaluated and a balloon burst was observed, as the user had percutaneously punctured the balloon to remove the catheter from the user.The evaluation found no pinch or blockage on the returned catheter as water could be introduced into the lumen by using a needle syringe.However, a complete evaluation could not be performed due to the poor condition of the returned sample.The potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage.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 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 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 (1) who are or have been allergic to natural rubber latex (2) with known allergy to silver coated catheter".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. 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 Key8567060
MDR Text Key143697512
Report Number1018233-2019-02232
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741016769
UDI-Public(01)00801741016769
Combination Product (y/n)N
PMA/PMN Number
K910318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 06/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/01/2021
Device Model Number0165SI18
Device Catalogue Number0165SI18
Device Lot Number8DT7053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2018
Date Manufacturer Received05/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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