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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 FOLEY TRAYS

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C.R. BARD, INC. (COVINGTON) -1018233 FOLEY TRAYS Back to Search Results
Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2021
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 folding up on its own and stucked together at the point where the foley was placed in and the user had to rip it apart.It almost looked like there might be a hole inside.The event happened in the morning on a coude catheter kit and also for 2 regular temperature sensing kits.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿operator error".It is unknown whether the device had met relevant specifications.It was unknown whether the product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.Corrections: d,g,f,h h11: section a through f - the information provided by bd represents all 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 catheter folding up on its own and sticking together at the point where the foley was placed in and the user had to rip it apart.It almost looked like there might be a hole inside.The event happened in the morning on a coude catheter kit and also for 2 regular temperature sensing kits.
 
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Brand Name
FOLEY TRAYS
Type of Device
FOLEY TRAYS
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11468511
MDR Text Key239379192
Report Number1018233-2021-01219
Device Sequence Number1
Product Code EZL
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 07/30/2021
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/16/2021
Initial Date FDA Received03/12/2021
Supplement Dates Manufacturer Received07/27/2021
Supplement Dates FDA Received08/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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