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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. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER Back to Search Results
Catalog Number 119314
Device Problems Fracture (1260); Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2024
Event Type  malfunction  
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.
 
Event Description
It was reported that immediately after the foley catheter was placed, urine started leaking from the shaft, so a different catheter was replaced.On visual inspection, they found a crack in the shaft near the funnel.The inlet tube was cut and discarded the bag.
 
Manufacturer Narrative
The reported event is confirmed - manufacturing related.A potential root cause for this failure could be imperfection in balloon due to process.Photo: received four (4) photo samples.Three photo samples showcase an overview an all-silicone foley catheter.Fourth photo sample showcase a drawing with native writing.Visual: received one (1) used all-silicone foley catheter without original packaging.Visual inspection noted a pinhole in the catheter shaft measuring (0.021") and (0.3930") from the trifurcation.This is out of specification which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review is not required because labeling could not have prevented the reported failure.Correction: d,e,f,h 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.H3 other text : the actual/suspected device was inspected.
 
Event Description
It was reported that immediately after the foley catheter was placed, urine started leaking from the shaft, so a different catheter was replaced.On visual inspection, they found a crack in the shaft near the funnel.The inlet tube was cut and discarded the bag.
 
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Brand Name
BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
Type of Device
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 Key18704489
MDR Text Key336522650
Report Number1018233-2024-00745
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741039843
UDI-Public(01)00801741039843
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K070582
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 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number119314
Device Lot NumberMYHW3389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/13/2023
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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