MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number 301940

Device Problems Fungus in Device Environment (2316); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

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 foreign spots "suspected to be mold" were found on the bd syringe¿ with needle plunger before use while priming.The following information was provided by the initial reporter, translated from (b)(6) to english: "during priming, it's noticed that the plunger rod spotted and suspected to be moldy.".

Manufacturer Narrative

H.6.Investigation: bd has been provided with photos and a sample for catalog: 301940 lot: 1803215 to investigate for this record.After evaluation of the returned sample, bd identified the foreign matter as embedded contamination in the plunger.As a result, bd was able to verify the reported issue.The embedded particles defect was produced in the screw of the injection molding machine.Due to the high working temperatures (about 300ºc), some particles of plastic and rest of oil from the polyethylene can remain stuck on the internal walls of the mold and get burnt.During normal production some particle may be detached from the screw being injected and remaining embedded in molded piece.This a cosmetic defect which has no risk to the health because the plastic piece is embedded in syringe plunger without possibility of being detached from it.Dhr showed no indication of the alleged defect.H3 other text.

Event Description

It was reported that foreign spots "suspected to be mold" were found on the bd syringe¿ with needle plunger before use while priming.The following information was provided by the initial reporter, translated from chinese to english: "during priming, it's noticed that the plunger rod spotted and suspected to be moldy.".

• Brand Name: BD SYRINGE WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8911690
• MDR Text Key: 155700775
• Report Number: 3002682307-2019-00457
• 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: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 301940
• Device Lot Number: 1803215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other