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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 COUNCILL MODEL
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL MODEL Back to Search Results
Model Number 0196L22
Device Problems Inadequate Instructions for Healthcare Professional (1319); Expiration Date Error (2528); Material Split, Cut or Torn (4008); Device Fell (4014)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2019
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 the catheter fell out of the patient with a large slit found on the balloon.Per sample evaluation, it was found that the catheter datecode appeared to have a printing error, the catheter packaging was missing an expiration date, and according to the (b)(6), the catheter was expired.
 
Manufacturer Narrative
The reported event was confirmed as a packaging related issue.A red rubber two way lubricath catheter was returned with a 10 cc slip tip syringe with its original packaging.In the investigation, it was found that the 76cm0118 release date 06aug2004 does not match the lot number format according to the standard.Also it was found that the expiration date was missing.A potential root cause for this issue could be "operator error" error during the label printing process".The packaging failed specifications.There does appear to be a relationship between the event and the packaging as the lot was found to be in an incorrect format and the expiration date was missing.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not completed as it unlikely the user would cause this issue.
 
Event Description
It was reported that the catheter fell out of the patient with a large slit found on the balloon.Per sample evaluation, it was found that the catheter datecode appeared to have a printing error, the catheter packaging was missing an expiration date, and according to the nogales jde search, the catheter was expired.
 
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Brand Name
BARDEX® LUBRICATH® FOLEY CATHETER COUNCILL MODEL
Type of Device
LUBRICATH
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9653528
MDR Text Key181838708
Report Number1018233-2020-00687
Device Sequence Number1
Product Code EZC
UDI-Device Identifier00801741017957
UDI-Public(01)00801741017957
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 03/20/2020
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 Health Professional
Device Expiration Date03/31/2007
Device Model Number0196L22
Device Catalogue Number0196L22
Device Lot Number76CM0118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2019
Initial Date Manufacturer Received 01/09/2020
Initial Date FDA Received01/31/2020
Supplement Dates Manufacturer Received03/16/2020
Supplement Dates FDA Received03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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