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

Catalog Number	381437
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
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 the bd insyte¿ autoguard¿ shielded iv catheter needle failed to retract after the insertion.The following information was provided by the initial reporter: "needle failed to retract from iv after insertion.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-nov-2022.H6: investigation summary our quality engineer inspected the sample submitted for evaluation.Bd received one unsealed 20ga x 1.16in.Insyte autoguard.The unit was attempted to be retracted but failed.The button seemed to be stuck and would not click all the way.The device was microscopically analyzed for any damage to the grip and needle hub, but no damage was discovered.The coils also were inspected but no defects were discovered.The device was then forcefully retracted and then placed back into its original position, but then it was able to retract successfully without any issues.The reported issue was confirmed.Although adhesive was not present on the device, during manufacturing a station alignment may cause adhesive to be on the outside of the hub, causing partial or no retraction.Since the button was unable to be pressed originally, it can be assumed that there was some adhesive that was missed in the microscopic analysis and was then taken off after forcefully retracted.Or the very top coil near the button assembly was stuck, preventing the button from being pressed all the way.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle failed to retract after the insertion.The following information was provided by the initial reporter: "needle failed to retract from iv after insertion.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15922053
• Report Number: 1710034-2022-00750
• Device Sequence Number: 6698679
• Product Code: FOZ
• UDI-Device Identifier: 00382903814374
• UDI-Public: (01)00382903814374
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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 Catalogue Number: 381437
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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