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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER Back to Search Results
Model Number 0165L16
Device Problems Deflation Problem (1149); Leak/Splash (1354); Device Dislodged or Dislocated (2923)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2019
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 a foley catheter deflated and fell out of a patient.The patient reported that while in bed, the bed was wet and upon inspection the catheter was found, balloon intact.Placement of another foley catheter was not required.
 
Event Description
It was reported that a foley catheter deflated and fell out of a patient.The patient reported that while in bed, the bed was wet and upon inspection the catheter was found, balloon intact.Placement of another foley catheter was not required.
 
Manufacturer Narrative
The reported event is inconclusive as photo received was inadequate to perform evaluation.A potential root cause for this failure mode could be user related (example: contact with sharp object)/mechanical failure/operator error/thin rubberize layer).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: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation of needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.".
 
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Brand Name
BARDEX® LUBRICATH® FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8663139
MDR Text Key146983127
Report Number1018233-2019-02860
Device Sequence Number1
Product Code EZC
UDI-Device Identifier00801741017483
UDI-Public(01)00801741017483
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number0165L16
Device Catalogue Number0165L16
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2019
Initial Date Manufacturer Received 05/13/2019
Initial Date FDA Received06/03/2019
Supplement Dates Manufacturer Received06/11/2019
Supplement Dates FDA Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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