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

Model Number	392523
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2-3 bd insyte¿ autoguard¿ bc pro shielded iv catheters experienced a needle that would not retract.The following information was provided by the initial reporter: the white button was already pushed out.Unable to thread the catheter off the needle.The needle never retracted at all after several attempts.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) medical center (fka (b)(6)).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed an open package for a 22g insyte autoguard bc pro from lot number 2160897.The affected device was not visible in either photograph.Since the affected physical samples were not returned for investigation, the functionality of the device could not be tested and since the reported issues could not be demonstrated in the photographs, the reported issue could not be confirmed.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 2-3 bd insyte¿ autoguard¿ bc pro shielded iv catheters experienced a needle that would not retract.The following information was provided by the initial reporter: the white button was already pushed out.Unable to thread the catheter off the needle.The needle never retracted at all after several attempts.

• Brand Name: INSYTE AUTOGARD BD PRO CATHETER
• 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: 15912104
• Report Number: 1710034-2022-00741
• Device Sequence Number: 5361551
• Product Code: FOZ
• UDI-Device Identifier: 30382903925231
• UDI-Public: 00382903925230
• 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): 02/01/2023

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: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 392523
• Device Catalogue Number: 392523
• Device Lot Number: 2160897
• 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: 11/09/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 12/03/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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