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

Catalog Number	381033
Medical Device Problem Codes	Retraction Problem (1536); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ bc shielded iv catheter needle would not retract.The following information was provided by the initial reporter: had an iv not auto retract upon pushing the button.I had to take the needle out of the patient and reattempt the iv start as i could not get the cannula away from the needle point.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photograph submitted for evaluation.Bd received one photograph which displayed multiple insyte autoguard needles and shields.All but one needle appeared to be fully retracted.One needle was fully extended; however, it appeared that the white button had been pressed to activate the safety mechanism.Since the needle remained extended, the reported issue was confirmed.What appeared to be adhesive was observed on the needle hub and likely bonded the needle hub to the grip, which prevented needle retraction.This type of damage may occur during manufacturing if the adhesive is placed outside the needle hub.A device history record review was performed.A trend has been identified for the reported failure and corrective actions have been initiated to investigate this type of incident and identity the root cause.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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: 17839441
• Report Number: 1710034-2023-01123
• Device Sequence Number: 20775991
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: (01)00382903810338
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: Other
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 381033
• Device Lot Number: 1264054
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• 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