MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO WINGED 20GX1"; INTRAVASCULAR CATHETER

Catalog Number	382933
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insyte autoguard bc pro winged 20gx1" the needle would not retract.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: the needle retraction mechanism did not work when i pressed the activator button (it stayed on).
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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 27-jan-2023.Investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one 20g x 1.0in insyte autoguard device from lot number 1350065.The safety mechanism had been activated and the needle was received partially retracted.The needle hub appeared to be caught on a deformed component at the interface between the grip and barrel.The damage appears to be a dent at the barrel/grip interface that is reducing its inside¿s diameter prohibiting full retraction.The damage seen at the barrel/grip interface has no stress marks that would indicate physical force was applied from the outside the unit.Since the defect was located within the grip and barrel, this was likely caused during assembly and could be attributable to misalignment in the manufacturing process.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 while using bd insyte autoguard bc pro winged 20gx1" the needle would not retract.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: the needle retraction mechanism did not work when i pressed the activator button (it stayed on).

• Brand Name: BD INSYTE AUTOGUARD BC PRO WINGED 20GX1"
• 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: 16211023
• Report Number: 1710034-2023-00017
• Device Sequence Number: 4454126
• Product Code: FOZ
• UDI-Device Identifier: 00382903829330
• UDI-Public: (01)00382903829330
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/07/2023

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: 11/30/2024
• Device Catalogue Number: 382933
• Device Lot Number: 1350065
• 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: 12/30/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 03/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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
• Patient Sex: Unknown