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

Catalog Number	382512
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of needle retraction failure with lot 6022552 regarding item #382512.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of needle shielding failure with lot 6022552 regarding item #382512.The device history record for the finished lot 6022552 has been reviewed.Non-conformance # 201215409 was initiated for non-retraction during built of lot number 5309614, which could potentially be related to this complaint.No process deviations were found.A review of the applicable risk documents indicates that the potential risk of the reported events was assessed appropriately in the risk management documentation.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
G.4.K201075; k251654.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 a needle partially retracted.Per the site they have had 2 experiences where the needle failed to retract.Customer response on (b)(6) 2026: can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2026 when you pressed the button, did the needle fully retract? no, 1st needle did not retract at all.2nd, random sample retracted a little, then stopped, then we ¿pumped¿ the trigger and it final retracted.Did not function smoothly and would have presented a safety risk in practice.Did the needle retract slower than normal? see above.Did the needle start retracting and then stop, leaving the needle exposed? yes, see above did the needle not move at all after pressing the button? yes, 1st needle did not retract, which is what alerted us to randomly try another from the same lot# did the button depress? yes, both times.Was there any harm/injury to patient or device user? no.Please describe any diagnostics or medical treatment provided if harm/injury occurred.Na.

• Brand Name: 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: 25137105
• Report Number: 1710034-2026-00498
• Device Sequence Number: 9453846
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: (01)00382903825127(17)281031(10)6022552
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2026

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: Health Professional
• Device Catalogue Number: 382512
• Device Lot Number: 6022552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 06/26/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/22/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown