MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. Insyte AUTOGUARD; Peripheral IV Catheters

Catalog Number	381023
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was determined through the investigation that bd insyte autog bc global needle was damaged or defective.Customer report: t was reported that "the tip of the catheter needle became deformed during the patient's infusion" actions taken at the healthcare facility to manage the patient: the faulty device was removed.Another device was used.Response received on:7/27/2026 when was the defect identified? during or after use.
Additional Manufacturer Narrative
This mdr is the result of an investigation finding: investigation results two photographs and one retracted insyte autoguard needle were provided for investigation.Our quality engineer inspected the sample and photographs submitted for evaluation.Examination of the returned device found that the needle was bent at the flash notch.The remaining wall thickness at the notch was found to be out of specification, which was identified as a likely contributing factor to the reported damage.The findings indicated that the reported condition appeared to be associated with manufacturing.The appropriate manufacturing personnel have been notified.A review of risk management documentation was performed and indicated that the potential risk associated with the reported event had been assessed appropriately.

• 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 ; +1(847)393-5694
• MDR Report Key: 50933033
• Report Number: 1710034-2026-01048
• Device Sequence Number: 9734419
• Product Code: FOZ
• UDI-Device Identifier: 00382903810239
• UDI-Public: (01)00382903810239
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K251654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 381023
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/29/2026
• 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