MAUDE Adverse Event Report: BECTON DICKINSON BD EMERALD SYRINGE 5ML 23X1 AN; PISTON SYRINGE

Catalog Number 307756

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 01/11/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the hub is not aligned correctly with a bd emerald syringe 5ml 23x1 an.This occurred on 2 separate occasions, however during use, the date/time and or patient information is unknown.The following information was provided by the initial reporter: hub of the syringe is not straight meaning does not have 90% angle.Resulting in pain while withdrawing blood.

• Brand Name: BD EMERALD SYRINGE 5ML 23X1 AN
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9654326
• MDR Text Key: 181752939
• Report Number: 2243072-2020-00117
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 307756
• Device Lot Number: 9092879
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other