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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER Back to Search Results
Model Number A947316
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the surestep foley tray system did not contain 10cc syringe filled with sterile water.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.Based on patient code 2645 the product was not used on the patient.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be ¿incorrect operation ¿.The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.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.
 
Event Description
It was reported that the surestep foley tray system did not contain 10cc syringe filled with sterile water.
 
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Brand Name
SURESTEP FOLEY TRAY SYSTEM BARD LUBRI-SIL FOLEY CATHETER
Type of Device
SURESTEP FOLEY TRAY
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key11889447
MDR Text Key254651228
Report Number1018233-2021-03045
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741074141
UDI-Public(01)00801741074141
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 08/12/2021
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
Device Expiration Date04/29/2021
Device Model NumberA947316
Device Catalogue NumberA947316
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/05/2021
Initial Date FDA Received05/26/2021
Supplement Dates Manufacturer Received08/12/2021
Supplement Dates FDA Received09/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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