MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 60ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Model Number 309653

Device Problem Fungus in Device Environment (2316)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: one sample was received for evaluation, and it came in a sealed packaging blister.A visual inspection was performed.It has embedded degraded resin in the barrel flange area and with the top part of the barrel.The sample was scraped by using a knife, confirming the embedded resin.The embedded degraded resin can occur at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the barrel and hot-runner system of the tooling mold and press.The degraded resin can break loose and be molded into components.Inspections at the molding and assembly processes have special attention to this defect.During the accountability meeting, the production coordinator addressed the complaints.The complaint history for catalog# 309653 was done from 2018 to june 2020 with this customer.This is the 2nd complaint for any defect, the 1st complaint was reported in sept 2018.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the embedded degraded resin can occur at the startup of an injection mold/press or intermittently during the injection molding process.Degraded resin inherently builds up in the barrel and hot-runner system of the tooling mold and press.The degraded resin can break loose and be molded into components.Rationale: capa not required at this time.

Event Description

It was reported that bd 60ml syringe luer-lok¿ tip had mold and black particles.This was discovered before use.The following information was provided by the initial reporter: material no.: 309653 batch no.: 9303403.It was reported that customer found syringe with what looked to be mold and black particles.

• Brand Name: BD 60ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10175767
• MDR Text Key: 203174658
• Report Number: 1911916-2020-00570
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309653
• Device Catalogue Number: 309653
• Device Lot Number: 9303403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2019
• 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