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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER Back to Search Results
Catalog Number 0165L18
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.A labeling review cannot be completed due to no product catalog number provided.The device was not returned.
 
Event Description
It was reported that the foley catheter was not draining.The rn irrigated the catheter with no resistance and attempted to withdraw the fluid from the balloon< however only 1.5ml returned.The rn returned the 1.5ml to the catheter.The foley catheter then came out spontaneously with the balloon still inflated.
 
Event Description
It was reported that the foley catheter was not draining.The rn irrigated the catheter with no resistance and attempted to withdraw the fluid from the balloon< however only 1.5ml returned.The rn returned the 1.5ml to the catheter.The foley catheter then came out spontaneously with the balloon still inflated.
 
Manufacturer Narrative
The reported event was confirmed as manufacturing related.A used latex foley was returned still attached to the drainage bag.The balloon was inflated with 10 ml with a luer lock syringe.The balloon was found to be asymmetric.No other issues were observed during inflation.The balloon deflated with no issues.The proximal side of the catheter was placed inside an house leg bag.Drainage through the catheter into the attached bag was observed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not conducted as only the manufacturing lot number was obtained which only correlates to the catheter subassembly.This product is sold in single strip packets, trays, and as product subassembly with various labeling.There was not enough information to determine the labeling to be inadequate.
 
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Brand Name
BARDEX® LUBRICATH® FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8362205
MDR Text Key136881053
Report Number1018233-2019-00995
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 06/04/2019
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 Expiration Date01/26/2023
Device Catalogue Number0165L18
Device Lot NumberMCCN4142
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2019
Initial Date Manufacturer Received 01/31/2019
Initial Date FDA Received02/22/2019
Supplement Dates Manufacturer Received05/25/2019
Supplement Dates FDA Received06/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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