MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE WITH BD TWINPAK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303391
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that before use of the bd 3ml syringe with bd twinpak the nurse noticed a foreign substance inside of the syringe.The following information was provided by the initial reporter: "one of our er nurses noticed a foreign substance in the syringe she was about to use on a patient.So far, this is an isolated incident, however we are still in the process of examining the rest of our stock throughout the hospital.".
Event or Problem Description
It was reported that before use of the bd 3ml syringe with bd twinpak the nurse noticed a foreign substance inside of the syringe.The following information was provided by the initial reporter: "one of our er nurses noticed a foreign substance in the syringe she was about to use on a patient.So far, this is an isolated incident, however we are still in the process of examining the rest of our stock throughout the hospital.".
Additional Manufacturer Narrative
Investigation summary: three photos and one used 3ml syringe with twinpak and an open blister package were received.The sample was visually evaluated.The package was confirmed to be from batch #9024649 (p/n 303391).The syringe had unidentified clear liquid residue throughout the fluid path.The syringe barrel was observed to have four brown foreign matter particles, larger than level 3 in size, embedded in the barrel wall.A few smaller particles were also observed.The barrel was confirmed to be from mold c-240 cavity 75.The embedded foreign matter the size observed is rejectable per product specification.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Potential root cause for the embedded foreign matter defect is associated with the molding process.No corrective actions are necessary based on the defective rate identified.Batch 9024649 is considered in compliance with our product specification requirements.

• Brand Name: BD 3ML SYRINGE WITH BD TWINPAK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8587095
• Report Number: 1213809-2019-00512
• Device Sequence Number: 1998526
• Product Code: FMI
• UDI-Device Identifier: 30382903033912
• UDI-Public: 30382903033912
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 303391
• Device Lot Number: 9024649
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other