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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER Back to Search Results
Catalog Number 1758SI16
Device Problems Fracture (1260); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2023
Event Type  malfunction  
Event Description
It was reported that water leakage from the foley catheter balloon was confirmed during the pre-test.It was noted that the balloon damage could not be confirmed.It was stated that they found a crack near the valve.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
 
Manufacturer Narrative
The reported event is confirmed - manufacturing related.A potential root cause for this failure could be imperfection in balloon due to process.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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.The actual/suspected device was inspected.
 
Event Description
It was reported that water leakage from the foley catheter balloon was confirmed during the pre-test.It was noted that the balloon damage could not be confirmed.It was stated that they found a crack near the valve.
 
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Brand Name
BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
Type of Device
SILICONE FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18132096
MDR Text Key328633147
Report Number1018233-2023-08102
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1758SI16
Device Lot NumberNGGS0162
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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