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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. TEMPERATURE SENSING FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER Back to Search Results
Model Number 129416M
Device Problems Inaccurate Flow Rate (1249); Leak/Splash (1354); No Flow (2991)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2020
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 foley catheter was leaking and the nurse withdrew the catheter, and there was only 8 cc of fluid in the balloon.She reinflated the balloon with 10 cc and the foley would not drain.She scanned the patient¿s bladder and found 200cc of residual urine.
 
Event Description
It was reported that foley catheter was leaking and the nurse withdrew the catheter, and there was only 8 cc of fluid in the balloon.She reinflated the balloon with 10 cc and the foley would not drain.She scanned the patient¿s bladder and found 200cc of residual urine.
 
Manufacturer Narrative
The reported event was unconfirmed.The device met specifications.The device was being used for treatment.An eggshell bardex ic temperature sensing catheter was returned opened with its original packaging.The catheter's drainage funnel was attached to a di faucet.When the faucet was turned on, water was seen coming out of the catheter's drainage eyes.The catheter tip was placed in the outlet port of an in-house drainage bag filled with di water.Water was seen coming out of the drainage funnel.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.¿ 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.
 
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Brand Name
BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
Type of Device
TEMPERATURE SENSING FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9945803
MDR Text Key187792700
Report Number1018233-2020-02499
Device Sequence Number1
Product Code MJC
UDI-Device Identifier00801741039775
UDI-Public(01)00801741039775
Combination Product (y/n)N
PMA/PMN Number
K040658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number129416M
Device Catalogue Number129416M
Device Lot NumberMCDV5430
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2020
Date Manufacturer Received05/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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