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

Model Number	381534
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on 01-dec-2022.Medwatch report # mw (b)(4).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 prior to use with bd insyte autoguard winged pnk 20ga x 1.16i foreign matter was found in 12 devices.There was no report of patient impact.The following information was provided by the initial reporter: black speckles in the plastic cap of the needle.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 12-dec-2022.Our quality engineer inspected the samples submitted for evaluation.Bd received two sealed 20g x 1.16in.Insyte autoguard winged units from lot number 2208315.A gross visual inspection found that both units had black specks of fm embedded in the needle cover.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect.The material was determined to be burnt particulate resin (non-foreign).The black specks were most likely created as part of the molding process.Burnt imbedded resin specks result from material build up in the barrel/screw.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
Event or Problem Description
It was reported prior to use with bd insyte autoguard winged pnk 20ga x 1.16i foreign matter was found in 12 devices.There was no report of patient impact.The following information was provided by the initial reporter: black speckles in the plastic cap of the needle.

• Brand Name: BD INSYTE AUTOGUARD WINGED PNK 20GA X 1.16I
• Common Device Name: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15925165
• Report Number: 1710034-2022-00752
• Device Sequence Number: 20415550
• Product Code: FOZ
• UDI-Device Identifier: 00382903815340
• UDI-Public: (01)00382903815340
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 01/12/2023

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: 07/31/2025
• Device Model Number: 381534
• Device Catalogue Number: 381534
• Device Lot Number: 2208315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Patient Sex: Unknown