MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD EMERALD¿ SYRINGE

Catalog Number 307736

Device Problems Loose or Intermittent Connection (1371); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that there was "loose plastic material" and "black ink" on the bd emerald¿ syringe luer slip area.

Manufacturer Narrative

Investigation summary: a review of the device history record could not be performed as a lot number was not provided for this incident.Bd has been provided with the affected sample.After the evaluation of the returned sample, bd could confirm the flash in the tip of the syringe and identified the foreign matter as ink particles in the tip.Bd confirms the reported issue.After analyzing the affected sample provided to the manufacturing site for evaluation, bd could see the flash in the tip and the reported foreign matter and confirm the reported issue.The marking process of bd emerald syringes is an approved and highly capable printing technology for medical devices.In this case, during the scale marking, a blockage occurred in the machine and the flash and ink presence in the tip of the barrel was produced.This issue happened in the barrel marking machine due to a punctual failure in this process.Bd concludes that it has been an isolated case with a negligible frequency of occurrence.

Event Description

It was reported that there was "loose plastic material" and "black ink" on the bd emerald¿ syringe luer slip area.

• Brand Name: BD EMERALD¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8171000
• MDR Text Key: 131178710
• Report Number: 3002682307-2018-00316
• 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: 01/18/2019

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: 307736
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 11/30/2018
• Supplement Dates FDA Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other