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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER Back to Search Results
Catalog Number 165812
Device Problem Material Puncture/Hole (1504)
Patient Problem Discomfort (2330)
Event Date 01/18/2024
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 the diffusion from silicone foley catheter balloon.The customer have on all three sizes of (b)(6) experienced that the catheter balloon which was filled with the provided syringe.That after 3 weeks the customer had a volume of 4 ml each in the balloon, this creates discomfort for the user.No medical intervention was reported.
 
Manufacturer Narrative
The reported event was unconfirmed.No root cause could be found because the reported event was unconfirmed.It was received one 2 way all silicone foley catheter and water syringe in its unopened original package.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and concentricity was found within specification.Catheter rested with no leaks.The inhouse syringe was connected and it was able to passively return the 10 ml with no issues or cuffing.The same test was performed with the returned syringe and no defects were evidenced.A dhr is not required since the reported failure was unconfirmed.The reported event is unconfirmed a labeling review is not required.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 diffusion from silicone foley catheter balloon.The customer have on all three sizes 12 (lot# mygy2871/ 14 (lot# mygy0098)/16 (lot# mygv0659)) experienced that the catheter balloon which was filled with the provided syringe.That after 3 weeks the customer had a volume of 4 ml each in the balloon, this creates discomfort for the user.No medical intervention was reported.
 
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Brand Name
BARDEX® 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 Key18836747
MDR Text Key337013879
Report Number1018233-2024-01132
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number165812
Device Lot NumberMYGY2871
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/14/2024
Initial Date FDA Received03/05/2024
Supplement Dates Manufacturer Received05/23/2024
Supplement Dates FDA Received05/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2023
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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