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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD PNK 20GA X 1.16IN INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD PNK 20GA X 1.16IN INTRAVASCULAR CATHETER Back to Search Results
Model Number 381834
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: our quality engineer inspected the photographs submitted for evaluation. Bd received two photos displaying four units. A visual inspection of the provided photos found that of the four photographed units and one had loose black foreign matter specks inside the packaging. All of the units were also observed to be sealed. As the device was sealed, the defect of foreign matter can be attributed to the manufacturing or packaging process. Preventative maintenance and visual inspections are performed during manufacturing, at regular intervals, to mitigate the risk from this type of defect. A device history record review showed no non-conformance's associated with this issue during the production of this batch. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that insyte autoguard pnk 20ga x 1. 16in had foreign matter. This occurred on 6 occasions. The following information was provided by the initial reporter: found during packaging, 6 catheters with particles inside.
 
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Brand NameINSYTE AUTOGUARD PNK 20GA X 1.16IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12563057
MDR Text Key274744797
Report Number1710034-2021-00855
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number381834
Device Catalogue Number381834
Device Lot Number0300761
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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