MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE STERILE, SINGLE USE; PISTON SYRINGE

Catalog Number 309646

Device Problems Fungus in Device Environment (2316); Contamination /Decontamination Problem (2895)

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

Event Date 01/11/2019

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 22 bd luer-lok¿ syringes sterile, single use were contaminated with mold presence.

Manufacturer Narrative

Investigation: fourty-nine 5ml syringes confirmed to be from batch # 8267575.Sixteen were observed to have no defect or particles outside the fluid path smaller than level 3 in size, which is acceptable per product specification.Thirty-three were observed to have loose greenish foreign matter particles on the barrel walls and the webs of the packaging outside the fluid path.The particles were larger than level 3 in size, which is rejectable per product specification.One was observed to have the fm on the tip in the fluid path and larger than level 1 in size, which is rejectable per product specification.The fm appears to be grease.One loose syringe with no package was found with no defects.Two samples were confirmed to be from batch # 8267572 (p/n 309646).No defects were found on both samples.Three representative 5ml ll syringes from batch 8267575, catalog # 309646 with visual foreign matter were tested for the presence of mold contamination by the bd canaan microlab.Each syringe was swabbed under aseptic conditions.Swab samples were taken from the location on each syringe with visual contamination and streaked to sabouraud dextrose agar(sda).Swab samples were also taken from the inside bottom web of each syringe package where visual foreign matter was present.The sda agar plates were incubated in the incubator for 7 days.Sda was selected for use during this investigation because it is commonly used for the cultivation of yeast and mold.The sda agar plates were examined for growth on the 7th day of incubation.No visual evidence of growth was present on any of the agar plates.Since no evidence of mold growth was observed on any of the agar plates, mold contamination may be ruled out as the contaminant of the three (3), bd 5ml luer-loktm syringes of lot#8267575, catalog # 309646 sampled during this investigation.Ftir test: using fourier transform infrared (ftir) spectroscopy and optical microscopy this study aimed to identify foreign material found on a 5ml luer lok syringe (lot# 8267575) we retrieved the material from the barrel surface using a tungsten needle then transferred to a slide for ftir spectroscopy.We collected an ftir spectrum and based on spectral library searches we conclude the fm is composed of silicone containing hydrocarbon lubricant.Production records from batch 8267575 show that repairs were made to bottom web cylinders during the time of production.The cylinders are used to guide the bottom web in the packaging process.Additionally, the grease found on syringes from batch 8267575 matches with the grease type used in machine parts at packaging to prevent excessive wear and equipment failure.Potential root cause for the foreign matter defect ¿grease¿ is associated with the packaging process.Grease is used to lubricate the bearings inside the cylinders which make direct contact to the bottom web.It is possible that during the repair, the outer portion of the cylinder was exposed to grease and not cleaned properly.This led to an isolated incident of contaminated bottom web that then contaminated the outside of the syringe.

Event Description

It was reported that 22 bd luer-lok¿ syringes sterile, single use were contaminated with mold presence.

• Brand Name: BD LUER-LOK SYRINGE STERILE, SINGLE USE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8312221
• MDR Text Key: 135703363
• Report Number: 1213809-2019-00155
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: 30382903096467
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 309646
• Device Lot Number: 8267575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other