MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO STRAIGHT, 18G X 1.16"; INTRAVASCULAR CATHETER

Model Number	392544
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insyte autoguard bc pro straight, 18g x 1.16" the needle would not retract.There was no report of patient impact.The following information was provided by the initial reporter: when needle is safetied it does not want to retract.
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: d10: device available for eval yes, d10: returned to manufacturer on: 07-nov-2022.H6: investigation summary.Our quality engineer inspected the samples submitted for evaluation.Bd received 13 18g x 1.16in insyte autoguard bc devices from lot number 2164968 for the investigation.A gross visual inspection of the returned unit shows 5 units that have been used and retracted in their barrels.The other 8 units were sealed in the package and had no signs of physical damage nor use.First the used units will be tested for retraction failure.The needles were pushed out of the units to reengage the safety button.Upon disengagement, the units retracted safely in the barrels.The safety buttons on the representative units were also activated and all the units retracted safely without resistance.Therefore, the reported issue couldn¿t be confirmed.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 while using bd insyte autoguard bc pro straight, 18g x 1.16" the needle would not retract.There was no report of patient impact.The following information was provided by the initial reporter: when needle is safetied it does not want to retract.

• Brand Name: BD INSYTE AUTOGUARD BC PRO STRAIGHT, 18G X 1.16"
• 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: 15696146
• Report Number: 1710034-2022-00632
• Device Sequence Number: 7367838
• Product Code: FOZ
• UDI-Device Identifier: 00382903925445
• UDI-Public: 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): 12/12/2022

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: 10/06/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 12/29/2022
• 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