MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 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	08/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s birthday was not provided, (b)(6) was used based on age of patient.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 while using 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: after inserting iv, needle does not retract.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.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 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: after inserting iv, needle does not retract.

• Brand Name: 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: 15695943
• Report Number: 1710034-2022-00633
• Device Sequence Number: 7359120
• Product Code: FOZ
• UDI-Device Identifier: 00382903925445
• UDI-Public: 00382903925445
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/31/2022

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?: No
• 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: 10/31/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 53 YR
• Patient Sex: Male