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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
Catalog Number 0165L14
Device Problems Burst Container or Vessel (1074); Device Dislodged or Dislocated (2923)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the catheter balloon had burst three times on different days.It was also stated that most recently on (b)(6) 2020 the patient got pain with no pattern as to when it occurred and had a tremendous desire to pass urine and felt like the catheter exploded.It was also reported that the catheter fell out of the patient and on check of the catheter balloon burst was found.On (b)(6) 2020, the catheter fell out with severe pain to the patient.On (b)(6) 2020, the catheter fell out with balloon deflated.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 was blocked.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 had balloon burst with no visible encrustation.It was also stated that there had been other changes for bypassing but no records of encrustation in notes.When checked the paper record on site 3 of the 4 changes of catheter were ngdz0222.There was no issue with storage of catheters.
 
Event Description
It was reported that the catheter balloon had burst three times on different days.It was also stated that most recently on (b)(6) 2020 the patient got pain with no pattern as to when it occurred and had a tremendous desire to pass urine and felt like the catheter exploded.It was also reported that the catheter fell out of the patient and on check of the catheter balloon burst was found.On (b)(6) 2020, the catheter fell out with severe pain to the patient.On (b)(6) 2020, the catheter fell out with balloon deflated.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 was blocked.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 had balloon burst with no visible encrustation.It was also stated that there had been other changes for bypassing but no records of encrustation in notes.When checked the paper record on site 3 of the 4 changes of catheter were ngdz0222.There was no issue with storage of catheters.
 
Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.Potential root cause for this failure mode could be user related (example: contact with sharp object)/ exposure to petrolatum based products mechanical failure/operator error.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: "do not use ointments or lubricants having a petrolatum base.They will damage latex." 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.H3 other text : the device was not returned.
 
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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 Key10577229
MDR Text Key208756632
Report Number1018233-2020-06182
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Catalogue Number0165L14
Device Lot NumberNGDZ0222
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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