MAUDE Adverse Event Report: BD BD SYRINGE BD 20 ML; SYRINGE, PISTON

Model Number 302830

Device Problem Contamination (1120)

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

Event Date 07/08/2021

Event Type  Injury  

Event Description

Bd luer-lok 20 ml syringe ref 302830 with an obvious white particulate within the sterile barrel.It was identified during the preparation of a sterile product the eve of (b)(6) 2021; the prep was discarded and did not reach the patient level.Fda safety report id# (b)(4).

• Brand Name: BD SYRINGE BD 20 ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 12160945
• MDR Text Key: 261712522
• Report Number: MW5102501
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 302830
• Device Catalogue Number: 302830
• Device Lot Number: 1113439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2021
• 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
• Patient Outcome(s): Required Intervention