MAUDE Adverse Event Report: BD BD 3 ML SYRINGE LUER-LOCK WITH BD PRECISIONGLIDE NEEDLE

Lot Number 5110711 14

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2015

Event Type  malfunction  

Event Description

A fuzzy white film was noted in the bevel of a bd 3ml syringe luer-lok with bd precisionglide needle.Lot # 5110711 14.Several other syringes from the same lot were opened and did not have this film on them, but the remaining syringes from the lot were pulled off the shelf.We do have the affected syringe and the remaining that were pulled from use.

• Brand Name: BD 3 ML SYRINGE LUER-LOCK WITH BD PRECISIONGLIDE NEEDLE
• Type of Device: BD 3 ML SYRINGE LUER-LOCK WITH BD PRECISIONGLIDE NEEDLE
• Manufacturer (Section D): BD; franklin lakes NJ
• MDR Report Key: 5334195
• MDR Text Key: 34761566
• Report Number: MW5058789
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 5110711 14
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1