MAUDE Adverse Event Report: BECTON DICKINSON BD STERILE CONVENIENCE TRAYS W/ 10 ML LUER-LOK TIP SYRINGES; SYRINGE, PISTON

Lot Number 002522

Device Problems Break (1069); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2020

Event Type  malfunction  

Event Description

Our pharmacy staff has founded a number of 10 ml syringes in each tray that was opened that were damaged.They all had a crack in syringe plunger and deemed them not usable.These syringes were found before any patient interaction and before use in compounding.In this specific lot number, lot # 0002522, two syringes were found in this particular tray to have a crack in the syringe plunger.

• Brand Name: BD STERILE CONVENIENCE TRAYS W/ 10 ML LUER-LOK TIP SYRINGES
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 10128476
• MDR Text Key: 194678264
• Report Number: MW5094880
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 002522
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1