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
G.4.K201075; k251654.E1.Address information was not provided; therefore, il was used as the state.Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.However, the reported defect of needle retraction slow is confirmed since a trend has been identified for the reported failure mode and corrective actions have been initiated to investigate this type of incident and identify the root cause.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Bd instyle autoguard bc needle failed to retract after nurse used it on patient.Infusion center manager and charge nurse randomly selected another from the same lot and the retractor stuck again, but with additional pressing finally retracted.All needles with this lot number were pulled from the floor and backstock.
Additional Manufacturer Narrative
Correction: it has been determined that this complaint is a duplicate to a previous complaint.The two potentially related mdr #s are attached in related report number grid.
Event or Problem Description
No.

• 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: 25319998
• Report Number: 1710034-2026-00561
• Device Sequence Number: 5318312
• Product Code: FOZ
• UDI-Device Identifier: 00382903825127
• UDI-Public: (01)00382903825127(10)6022552
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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