MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC NEEDLE

Catalog Number	305176
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd precisionglide¿ needle there was an issue with black spots/residue on end of needle.
Additional Manufacturer Narrative
Investigation: one sample was received for evaluation.A visual inspection was performed under a microscope.The needle assembly has no foreign matter.The plastic shield was also visually inspected and it was noted to have three embedded black specks, therefore failure mode is verified.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.
Event or Problem Description
It was reported with the use of the bd precisionglide¿ needle there was an issue with black spots/residue on end of needle.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8327827
• Report Number: 1911916-2019-00160
• Device Sequence Number: 11175201
• Product Code: FMI
• UDI-Device Identifier: 30382903051763
• UDI-Public: 30382903051763
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 03/04/2019

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: 305176
• Device Lot Number: 8232568
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/05/2019
• 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