MAUDE Adverse Event Report: BECTON DICKSON INFUSION THERAPY SYSTEMS INC. AUTOGUARD WINGED ANGIOCATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Lot Number 3109155

Patient Problems Failure of Implant (1924); Needle Stick/Puncture (2462)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

While attempting to start an intravenous on a neonate, the nurse noted that the catheter could not be advanced after entering the vein.The nurse removed the catheter and noted that the needle had sheered through the catheter, causing it to split.A second nurse attempted to place the intravenous, but had the same result.Both catheters were from the same lot number, so that lot number was removed.The intravenous was able to be started with another angiocatheter.Reference report: mw5149166.

• Brand Name: AUTOGUARD WINGED ANGIOCATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKSON INFUSION THERAPY SYSTEMS INC.; sandy UT 84070
• MDR Report Key: 18317929
• MDR Text Key: 330639886
• Report Number: MW5149165
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2023

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
• Device Operator: Health Professional
• Device Lot Number: 3109155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• Patient Sequence Number: 1
• Patient Age: 19 DA
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Ethnicity: Hispanic
• Patient Race: White