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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 Problems Deflation Problem (1149); Decrease in Pressure (1490)
Patient Problems No Consequences Or Impact To Patient (2199); 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.The device was not returned.
 
Event Description
It was reported that the balloons were deflated.
 
Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause was not chosen due to a lack of information.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not completed due to a lack of information.H11:section a through f - the information provided by bd represents all of 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 device was not returned.
 
Event Description
It was reported that the balloons were deflated.
 
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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 Key10385047
MDR Text Key203294342
Report Number1018233-2020-05091
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 11/15/2020
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 Other
Device Model Number165816
Device Catalogue Number165816
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/18/2020
Initial Date FDA Received08/10/2020
Supplement Dates Manufacturer Received10/25/2020
Supplement Dates FDA Received11/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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