MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; PERIPHERAL IV CATHETERS

Catalog Number	381423
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd insyte autoguard needle did not retract.The following information was provided by the initial reporter: the needle for the 22 gage angio catheter is not retracting.The (b)(6) clinic on (b)(6) showed me the issue.The nurses had to pull the needle back from the catheter that cause blood to leak out.I brought a different lot number of angio catheters to the clinic.The nurses opened the catheter and the needle retracted.I pulled all the angio catheters.2/10/2025: event date: this date is 29 january 2025.The negative outcome is the needles for this lot did not retract.The nurse held the catheter and pulled back on the needle.When she pulled back a little bit of blood splattered on the nurse¿s hand (the nurse was wearing gloves).
Additional Manufacturer Narrative
Investigation results: the complaint of needle retraction issues was confirmed from the representative 20g insyte autoguard units that were received in sealed packaging from lot #4229661.An inspection of the returned samples revealed no damage or defects on the returned samples; however, a functional test showed that the needles fully retracted but 4 of the 20 tested units exceeded the retraction specification time.The appropriate manufacturing personnel were notified of this complaint.A trend was identified for the reported failure and corrective actions have been implemented to investigate this type of incident and identify the root cause.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Additional information of fa#.

• Brand Name: BD INSYTE AUTOGUARD
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: 21411901
• Report Number: 1710034-2025-00262
• Device Sequence Number: 13089256
• Product Code: FOZ
• UDI-Device Identifier: 00382903811236
• UDI-Public: (01)00382903811236(10)4229661
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2025

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: 381423
• Device Lot Number: 4229661
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 06/13/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 04/07/2025; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MDS-25-5274
• Patient Sequence Number: 1
• Patient Sex: Unknown