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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 1758SI14
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2023
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 the urine did not pass through the foley catheter after insertion.Although they tried passing water through it with a syringe, it did not pass.Per follow-up information received from ibc on 20oct2023, stated that blockage was found in the foley catheter.
 
Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used drainage bag with inlet tube, sample port connector, catheter and tes.Visual inspection of the sample noted the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and rested with no leaks.With the syringe attached the balloon deflated passively under 1 minute with no leaks or cuffing noted.The photo sample was returned and could not be evaluated for the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.As the reported event is unconfirmed a labeling review is not required.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 the urine did not pass through the foley catheter after insertion.Although they tried passing water through it with a syringe, it did not pass.Per follow-up information received from ibc on 20oct2023, stated that blockage was found in the foley catheter.
 
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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 Key18064834
MDR Text Key327275067
Report Number1018233-2023-07804
Device Sequence Number1
Product Code MJC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K984136
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1758SI14
Device Lot NumberNGGX3341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2022
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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