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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
Model Number 165816
Device Problem Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that upon deflation and removal, the catheter balloon appeared to be asymmetrical.The complainant alleged that there was some resistance of the catheter when trying to remove, but the catheter was removed without medical intervention.
 
Manufacturer Narrative
The reported event was confirmed as cause unknown.Received 2 portions of a silicone catheter for evaluation.Also, received a photo showing a catheter with an asymmetrical balloon.Per visual inspection, no defects were found and it was observed that the shaft and inflation arm with valve are cut.Further inspection noted that there was a cut at the distal end of the shaft to 2 ¿ 5/8¿ (2.625¿) of the silicone catheter tip and inflation arm section with valve measured 1 - 1/2" (1.5¿).No other defects were observed.However, per visual inspection of the picture received, balloon asymmetrical was noted.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
 
Event Description
It was reported that upon deflation and removal, the catheter balloon appeared to be asymmetrical.The complainant alleged that there was some resistance of the catheter when trying to remove, but the catheter was removed without medical intervention.
 
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Brand Name
BARDEX® ALL-SILICONE FOLEY CATHETER
Type of Device
SILICONE FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7129896
MDR Text Key95669212
Report Number1018233-2017-06387
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741029752
UDI-Public(01)00801741029752
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 03/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2022
Device Model Number165816
Device Catalogue Number165816
Device Lot NumberNGBS1948
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2018
Date Manufacturer Received02/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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