MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML PRECISIONGLIDE SAFETY-LOK SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number	309582
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
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 precisionglide¿ safety-lok¿ syringe with detachable needle there looks to be a thread and brown dot on the inside of the syringe.
Additional Manufacturer Narrative
Investigation summary: one 3ml syringe in a fully sealed blister pack confirmed to be from batch #8311878 (b)(4).Was received.It was observed there was a brown embedded foreign matter particle in the threaded portion of the tip of the barrel.It appears to be burnt plastic and is larger than level 3 in size which 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.
Event or Problem Description
It was reported that before use of the bd 3ml precisionglide¿ safety-lok¿ syringe with detachable needle there looks to be a thread and brown dot on the inside of the syringe.

• Brand Name: BD 3ML PRECISIONGLIDE SAFETY-LOK SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8366981
• Report Number: 1213809-2019-00272
• Device Sequence Number: 2307380
• Product Code: FMF
• UDI-Device Identifier: 30382903095828
• UDI-Public: 30382903095828
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 309582
• Device Lot Number: 8311878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/23/2019
• 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