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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PERIPHERAL CATHETER INSERTION KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS, INC. PERIPHERAL CATHETER INSERTION KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number AC0182250
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/26/2020
Type of Reportable Event Malfunction
Event or Problem Description
Per nurse, "guidewire appears to be stuck.Unable to retract needle and push guidewire in".Manufacturer response for catheter, intravascular,therapeutic,short-term less than 30 days, peripheral catheter insertion kit (per site reporter).Alerted the bd rep for the facility that there was an issue.
 
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Brand Name
PERIPHERAL CATHETER INSERTION KIT
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key10514074
Report Number10514074
Device Sequence Number19471618
Product Code FOZ
UDI-Device Identifier00801741110931
UDI-Public(01)00801741110931
Combination Product (Y/N)N
Initial Reporter StateVA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/12/2020
Report Date (Section F) 08/12/2020
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
Operator of Device Health Professional
Device Model NumberAC0182250
Device Catalogue NumberAC0182250
Device Lot NumberREEQ4025
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Event Location Hospital
Date Report to Manufacturer09/10/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Date Report Sent to FDA08/12/2020
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