MAUDE Adverse Event Report: BECTON DICKINSON BD EMERALD SYRINGE 5ML

Catalog Number 307755

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical device expiration date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that bd¿ emerald syringe 5ml hub is bent.This occurred on 10 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: luer slip hub is bend in emerald syringes.

Event Description

It was reported that bd¿ emerald syringe 5ml hub is bent.This occurred on 10 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: luer slip hub is bend in emerald syringes.

Manufacturer Narrative

Investigation summary: dhr reviewed found no non-conformities.The team investigated the customer return samples and the retention samples of material number 307755 of lot number 18e14620.While the customer return sample confirmed that the complaint is authentic by visual inspection, the team has confirmed the complaint and has created a corrective action plan to resolve this issue immediately.1.Reviewed the assembled component storage and observed that the material stacking of three bags is the probable root cause of the problem.2.The racks will be provided for stacking and modify stacking from 3 to 2 layer or one layer of luer only when they are ready to be transported to the assembly area.

• Brand Name: BD EMERALD SYRINGE 5ML
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8474737
• MDR Text Key: 140821899
• Report Number: 2243072-2019-00631
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

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 Catalogue Number: 307755
• Device Lot Number: 18E14620
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 03/18/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other