MAUDE Adverse Event Report: BECTON DICKINSON BD 22 G INSYTE AUTOGUARD BC WINGED IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	382623
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Crna (certified registered nurse anesthetist) was inserting bd 22g insyte autoguard bc winged iv catheter.It was reported that the needle "split" the catheter.Upon gemba walk inspection the nurse had retracted the needle and disposed of the needle device, leaving only the plastic catheter for inspection after taking photos of the device.It appeared the needle had punctured the side of the catheter, rather than split it.Nurse denied manipulating the needle during insertion.No harm to patient, small bruise from blown site.

• Brand Name: BD 22 G INSYTE AUTOGUARD BC WINGED IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 24617060
• Report Number: MW5185288
• Device Sequence Number: 15849416
• Product Code: FOZ
• UDI-Device Identifier: 00382903826230
• UDI-Public: (01)00382903826230
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/10/2026

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 Model Number: 382623
• Device Lot Number: 4338236
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 147 KG
• Patient Race: Asian, White