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

Model Number	392534
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that ~10 bd insyte¿ autoguard¿ bc pro shielded iv catheter experienced difficult needle retraction.The following information was provided by the initial reporter: the 20g autoguard pro's are sometimes sticking prior to activating the safety for a split second.This happened a couple of times in the ed.Safety feature is still working though.
Event or Problem Description
It was reported that ~10 bd insyte¿ autoguard¿ bc pro shielded iv catheter experienced difficult needle retraction.The following information was provided by the initial reporter: the 20g autoguard pro's are sometimes sticking prior to activating the safety for a split second.This happened a couple of times in the ed.Safety feature is still working though.
Additional Manufacturer Narrative
H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED 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 ; 8015296192
• MDR Report Key: 15691713
• Report Number: 1710034-2022-00631
• Device Sequence Number: 20538541
• Product Code: FOZ
• UDI-Device Identifier: 00382903925346
• UDI-Public: 00382903925346
• 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): 12/02/2022

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: 04/30/2025
• Device Model Number: 392534
• Device Catalogue Number: 392534
• Device Lot Number: 2136382
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 10/28/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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