MAUDE Adverse Event Report: BD BD INSYTE-N AUTOGUARD WINGED; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 381511

Device Problems Degraded (1153); Difficult to Advance (2920)

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

Event Date 10/12/2022

Event Description

Attempted to start iv x 2 attempts with insyte-n autoguacd winged 24 gauge x 0.56in catheter (yellow packaging, with wings).However, when rn tried to advance catheter, catheter tip "shredded," and could not be advanced.This happened twice, and per nnp has also happened recently at pvh.Lot #2146599.Bd, (b)(4).

• Brand Name: BD INSYTE-N AUTOGUARD WINGED
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 15743821
• MDR Text Key: 303250701
• Report Number: MW5113075
• Device Sequence Number: 2
• 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: 10/20/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/01/2022
• Device Model Number: 381511
• Device Catalogue Number: 381511
• Device Lot Number: 2146599
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Female