MAUDE Adverse Event Report: BECTON DICKINSON IV CATH AUTOG 24G 3/4; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 318412

Device Problems Detachment of Device or Device Component (2907); Improper Flow or Infusion (2954); Material Too Soft/Flexible (4007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Patient complained about flimsy needle that came out of during the infusion.No adverse event or missed doses reported.Unknown if available for return; sending 22gm thicker needle 1" also reported headache and itching and history of migraines.Unknown if md aware.No further information provided.Indication: chronic inflammatory demyelinating polyneuritis.Needles used to infuse gammunex at above dose and frequency.Reported to (b)(6) by pt/caregiver.

• Brand Name: IV CATH AUTOG 24G 3/4
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 15976444
• MDR Text Key: 305504244
• Report Number: MW5113753
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 318412
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: GAMUNEX-C
• Patient Sex: Female