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

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

Peripheral iv 20 g of the bd insyte autoguard is malfunctioning for this lot.Have had 6 reported ivs malfunctioning.Staff go to take the cap off and the needle retracts before you even can use it.Fda safety report id# (b)(4).

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 12737978
• MDR Text Key: 280054026
• Report Number: MW5105068
• Device Sequence Number: 2
• Product Code: FOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/28/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1