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

Model Number	392544
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte autoguard bc pro straight needle would not retract.The following information was provided by the initial reporter: i have received more of the affected lot and a couple of the products which have been unsuccessfully safetied.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 16-dec-2022.H6: investigation summary: our quality engineer inspected the samples submitted for evaluation.Bd received five used 18g insyte autoguard bc pro units with no product documentation to indicate reference or lot number.A gross visual inspection found that unit (b)(4) had a spring that was snapped into two pieces.The remaining units were tested for retraction, and all retracted as intended.A damaged spring as seen in unit (b)(4) would likely cause a partial retraction or no retraction at all.Your reported issue was confirmed.A damaged spring may occur during manufacturing due to incorrect equipment settings on the spring feeder (feeder that loads the springs into the grips) or due to a machine misalignment as the needle hub is loaded into the grip.A 100% spring force check is performed in line and operators perform functional testing for needle retraction per the quality plan to mitigate the occurrence of this defect.In addition, 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 the bd insyte autoguard bc pro straight needle would not retract.The following information was provided by the initial reporter: i have received more of the affected lot and a couple of the products which have been unsuccessfully safetied.

• Brand Name: BD INSYTE AUTOGUARD BC PRO STRAIGHT
• 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: 15999778
• Report Number: 1710034-2022-00824
• Device Sequence Number: 6738540
• Product Code: FOZ
• UDI-Device Identifier: 00382903925445
• UDI-Public: (01)00382903925445
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/02/2023

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: 05/31/2025
• Device Model Number: 392544
• Device Catalogue Number: 392544
• Device Lot Number: 2164968
• 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: 11/28/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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