MAUDE Adverse Event Report: BD BD LUER-LOK TIP SYRINGE; SYRINGE, PISTON

Model Number REF 302832

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Black particulate found inside bd 30 ml syringe.Fda safety report id # (b)(4).

• Brand Name: BD LUER-LOK TIP SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD; franklin lakes NJ 07417
• MDR Report Key: 8837835
• MDR Text Key: 152697962
• Report Number: MW5088422
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 07/24/2019

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 Expiration Date: 04/30/2019
• Device Model Number: REF 302832
• Device Lot Number: 9120506
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1