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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. COUNCILL MODEL FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. COUNCILL MODEL FOLEY CATHETER Back to Search Results
Model Number 0196SI20
Device Problems Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/1980
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 foley catheter was defective and contaminated.Per follow-up information received via email on 15dec2020, the customer stated that the balloon emptied approximately 2-3 cc fluid.The resistance was met when attempting to remove the tube and the physician stated that the resistance was as normal as the tube passed through the fascia.The patient attempted to remove again, resistance was met, slightly added more pressure and the tube was successfully removed and the balloon appeared to remain semi-inflated.The patient experienced self limited bleeding at the left incision site and the bleeding was stopped after applying the pressure at the left incision site.
 
Event Description
It was reported that the foley catheter was defective and contaminated.Per follow-up information received via email on 15dec2020, the customer stated that the balloon emptied approximately 2-3 cc fluid.The resistance was met when attempting to remove the tube and the physician stated that the resistance was as normal as the tube passed through the fascia.The patient attempted to remove again, resistance was met, slightly added more pressure and the tube was successfully removed and the balloon appeared to remain semi-inflated.The patient experienced self limited bleeding at the left incision site and the bleeding was stopped after applying the pressure at the left incision site.
 
Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The device did not fail to meet relevant specifications.The reported failure was able to be reproduced.The product was used for treatment purposes.A potential root cause for this failure could be "defective/ with contamination components from the supplier".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not required, as the reported event was unlikely to be caused by the user.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 actual/suspected device was inspected.
 
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Brand Name
BARDEX I.C. COUNCILL MODEL FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11096357
MDR Text Key224692436
Report Number1018233-2020-22160
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741017032
UDI-Public(01)00801741017032
Combination Product (y/n)N
PMA/PMN Number
K910318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number0196SI20
Device Catalogue Number0196SI20
Device Lot NumberNGET1943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2021
Date Manufacturer Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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