MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 20ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Catalog Number 302830

Device Problem Material Discolored (1170)

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

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no.302830, batch no.9029691.It was reported that before use of the bd 20ml syringe luer-lok¿ tip the syringes are discolored.The following information was provided by the initial reporter: we noticed some discoloration on our 20ml syringes which caused my technicians to have concerns regarding sterility of the syringe and threw them out.They did save one but there were several syringes that had the same issue, they all had the same lot number 9029691 exp 01/31/2024.

Event Description

Material no.302830.Batch no.9029691.It was reported that before use of the bd 20ml syringe luer-lok¿ tip the syringes are discolored.The following information was provided by the initial reporter: we noticed some discoloration on our 20ml syringes which caused my technicians to have concerns regarding sterility of the syringe and threw them out.They did save one but there were several syringes that had the same issue, they all had the same lot number 9029691 exp 01/31/2024.

Manufacturer Narrative

Investigation: one (1) sample and one (1) photo were provided by the customer for investigation.Visual analysis of the returned sample showed a light brown streak in the thumb press of the plunger rod.One (1) was provided by the customer which shows the thumb press of the plunger rod.The light brown streak is visible the photo.This was determined to be embedded in the syringe.Embedded foreign matter 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 mold and press.The degraded resin can break loose and be molded into components.This is a cosmetic defect only and does not affect the integrity of the syringe.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.

Manufacturer Narrative

Correction: after further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.Discoloration of device is not considered to be a reportable malfunction.

Event Description

Material no.302830 batch no.9029691 it was reported that before use of the bd 20ml syringe luer-lok¿ tip the syringes are discolored.The following information was provided by the initial reporter: we noticed some discoloration on our 20ml syringes which caused my technicians to have concerns regarding sterility of the syringe and threw them out.They did save one but there were several syringes that had the same issue, they all had the same lot number 9029691 exp 01/31/2024.

• Brand Name: BD 20ML SYRINGE LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8662724
• MDR Text Key: 147049076
• Report Number: 1911916-2019-00549
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028307
• UDI-Public: 30382903028307
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 302830
• Device Lot Number: 9029691
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other