MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381544
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that while establishing and iv on patient the safety on the bd insyte¿ autoguard¿ iv catheter did not retract completely.The following information was provided by the initial reporter: verbatim: while establishing and iv on patient the safety on the bd insyte auto guard iv catheter did not completely engaged leaving the needle exposed and risk for injury.
Additional Manufacturer Narrative
The initial reporter also notified the fda.Medwatch report: (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.
Event or Problem Description
It was reported by customer that while establishing and iv on patient the safety on the bd insyte¿ autoguard¿ iv catheter did not retract completely.The following information was provided by the initial reporter: verbatim: while establishing and iv on patient the safety on the bd insyte auto guard iv catheter did not completely engaged leaving the needle exposed and risk for injury.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ IV 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 ; 8448235433
• MDR Report Key: 17014007
• Report Number: 1710034-2023-00575
• Device Sequence Number: 6872993
• Product Code: FOZ
• UDI-Device Identifier: 00382903815449
• UDI-Public: (01)00382903815449
• 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): 07/05/2023

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: 12/31/2025
• Device Model Number: 381544
• Device Catalogue Number: 382544
• Device Lot Number: 2250397
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2023
• 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