MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381533
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on 17 march, 2021.Medwatch report # mw5099327.Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that insyte autoguard winged pnk 20ga x 1.0in had a needle retraction failure.This occurred on 2 occasions.The following information was provided by the initial reporter: material no: 381533 batch no: 0119490.It was reported via medwatch report that two needles failed to fully retract.Event description per medwatch report states: two 20 gauge autoguard winged ivs - the needle did not completely retract on both.No injury within event.Report id# (b)(4).
Additional Manufacturer Narrative
Investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported that insyte autoguard winged pnk 20ga x 1.0in had a needle retraction failure.This occurred on 2 occasions.The following information was provided by the initial reporter: material no: (b)(4)batch no: 0119490 it was reported via medwatch report that two needles failed to fully retract.Event description per medwatch report states: two 20 gauge autoguard winged ivs - the needle did not completely retract on both.No injury withi event.Report id# (b)(4).

• Brand Name: INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11709095
• Report Number: 1710034-2021-00329
• Device Sequence Number: 3550312
• Product Code: FOZ
• UDI-Device Identifier: 00382903815333
• UDI-Public: 00382903815333
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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
• Operator of Device: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 381533
• Device Lot Number: 0119490
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1