MAUDE Adverse Event Report: BD BD INSYTE-N AUTOGUARD 24G X 0.56; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number REF 381411

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

Event Type  malfunction  

Event Description

Found angiocaths with this black substance all from same lot number/expiration.Bd insyte-n autoguard 24g x 0.56", lot 0275658, exp 2023-09-30; found 13 out of 4 boxes (50 in each box).Fda safety report id# (b)(4).

• Brand Name: BD INSYTE-N AUTOGUARD 24G X 0.56
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 11529579
• MDR Text Key: 241491378
• Report Number: MW5100127
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2021
• 13 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: REF 381411
• Device Catalogue Number: REF 381411
• Device Lot Number: 0275658
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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