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

Catalog Number	381444
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 the bd insyte¿ autoguard¿ shielded iv catheter needle partially retracted.The following information was provided by the initial reporter: the event was a needle stick to a provider who had started an iv and the needle did not retract.When discarding the "sharp" into the container, he was stuck in the finger by the exposed needle.Precautionary blood was drawn from both the provider and the patient.We examined multiple needles from same lot and had no other issues.We continue to use this style/brand needle.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle partially retracted.The following information was provided by the initial reporter: the event was a needle stick to a provider who had started an iv and the needle did not retract.When discarding the "sharp" into the container, he was stuck in the finger by the exposed needle.Precautionary blood was drawn from both the provider and the patient.We examined multiple needles from same lot and had no other issues.We continue to use this style/brand needle.
Additional Manufacturer Narrative
H6: investigation summary: a physical sample was not available for investigation but bd was provided with two photos of the issue for evaluation.A review of the device history record was performed for the reported lot, 2318741, and no quality issues were found during production.Our quality engineer reviewed the provided photos and observed a partial retraction of the needle.Therefore, based off the provided photos the engineer was able to verify the reported defect.However, without a physical sample available for testing the engineer could not determine a definitive root cause for the observed issue.The manufacturing facility has been notified of this incident and the findings.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17580731
• Report Number: 1710034-2023-00934
• Device Sequence Number: 20899869
• Product Code: FOZ
• UDI-Device Identifier: 30382903814443
• UDI-Public: (01)30382903814443
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 381444
• Device Lot Number: 2318741
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown