MAUDE Adverse Event Report: BD BD INSYTE AUTOGUARD 20 GA X 1.00; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 00382903814336

Device Problems Product Quality Problem (1506); Retraction Problem (1536)

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

Event Date 10/05/2022

Event Type  Injury  

Event Description

Er rn notified quality director that there were multiple bd 20 gauge angio catheters that were not retracting whenever nurse was attempting to obtain intravenous access to patients.Fda safety report id # (b)(4).

• Brand Name: BD INSYTE AUTOGUARD 20 GA X 1.00
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD
• MDR Report Key: 15562919
• MDR Text Key: 301507438
• Report Number: MW5112492
• 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: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00382903814336
• Device Lot Number: 2182197
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention