MAUDE Adverse Event Report: INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I; INTRAVASCULAR CATHETER

Catalog Number	381534
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 1.16i was not able to connect.The following information was provided by the initial reporter: it was reported bd insyte autoguard it will not connect to the infusion extension set.
Additional Manufacturer Narrative
H6: investigation summary: bd received a 20 gauge insyte autoguard winged iv catheter from lot 1078998 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the outer thread at the end of the luer was damaged and had grooves in the side of it.Based off the visual inspection the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect caused by a misalignment between the adapter and the manufacturing equipment.The manufacturing facility has been notified of this incident and the findings.A notification has been issued to all appropriate personnel to raise awareness of this issue and ensure proper alignment.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that insyte autoguard winged pnk 20ga x 1.16i was not able to connect.The following information was provided by the initial reporter: it was reported bd insyte autoguard it will not connect to the infusion extension set.

• Brand Name: INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12271220
• Report Number: 1710034-2021-00656
• Device Sequence Number: 4377223
• Product Code: FOZ
• UDI-Device Identifier: 00382903815340
• UDI-Public: 00382903815340
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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: 02/29/2024
• Device Catalogue Number: 381534
• Device Lot Number: 1078998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1