MAUDE Adverse Event Report: BECTON DICKINSON BD 50ML SYRINGES BULK STERILE CONVENIENCE PACK SYRINGE, PISTON

Model Number 309680

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

Found a screw at the bottom of the package of bd 50ml syringes bulk sterile convenience pack. Fda safety report id# (b)(4).

• Brand Name: BD 50ML SYRINGES BULK STERILE CONVENIENCE PACK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON
• MDR Report Key: 12665130
• MDR Text Key: 277857035
• Report Number: MW5104774
• 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: 10/15/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 309680
• Device Catalogue Number: 309680
• Device Lot Number: 1151564
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage