MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INSYTE AUTOGUARD PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381833
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Address information was not provided, therefore, xx was used as a place holder.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheters' needle was did not retract.The following information was provided by the initial reporter: "once i finished inserting the iv, i went to push the button for the needle retraction and the button didn't depress and the needle did not retract.I observed there was no obvious defect of the needle or the rest of the device.The device was the insyte autoguard shielded iv catheter 20g.The needle not retracting put me at a potential risk that did not happen, once i realized the device was defective, i placed the needle on the floor away from me and the patient until i completed the iv insertion and placed the needle into the sharps container promptly following the task.Exposed needle.No harm to the patient occurred.".
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review for lot 3167255 did not reveal any annotations or non-conformances during the manufacturing process related to this incident.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: INSYTE AUTOGUARD PNK 20GA X 1.0IN
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18521251
• Report Number: 1710034-2023-01538
• Device Sequence Number: 20520922
• Product Code: FOZ
• UDI-Device Identifier: 00382903818334
• UDI-Public: (01)00382903818334
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (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): 02/28/2024

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: 05/31/2026
• Device Catalogue Number: 381833
• Device Lot Number: 3167255
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown