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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 Decrease in Pressure (1490)
Patient Problem Hematuria (2558)
Event Date 12/15/2023
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 inserted in the angio room.It was removed naturally 3 to 4 hours after the surgery.There was only about 1cc of sterile water in the foley catheter and mild hematuria in the root.There was no abnormalities were detected throughout the catheter.Documents were included in the same bag as the actual item.No medical intervention was reported.
 
Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way all-silicone foley catheter.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 no leaks observed.With the syringe attached the balloon passively deflated without issue or cuffing and returning the 10ml of solution.No root cause could be found because the reported event was unconfirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The reported event is unconfirmed a labeling review is not required.Correction: d,g.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 inserted in the angio room.It was removed naturally 3 to 4 hours after the surgery.There was only about 1cc of sterile water in the foley catheter and mild hematuria in the root.There was no abnormalities were detected throughout the catheter.Documents were included in the same bag as the actual item.No medical intervention was reported.
 
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Brand Name
BARDEX® LUBRI-SIL® I.C. 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 Key18465185
MDR Text Key332980226
Report Number1018233-2023-09545
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,Followup
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1758SI14
Device Lot NumberNGGY5080
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2023
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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