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

Catalog Number	305124
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2018
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 that before use of the bd precisionglide¿ needle that the needle is dirty.There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
One photo was received for evaluation.The defect appears to be epoxy, therefore failure mode is verified.From the color and position the probable cause was epoxy on the caterpillar belts.This occurs if a misassembled needle, with epoxy, comes in contact with the caterpillar belts.No corrective actions are required at this time as the defect rate is within allowed quality limits per bd¿s specifications.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.A device history record review was completed.Assembly batch 6153707 had 11 visual inspections performed on 700 parts with zero defects noted.Daily cleaning was performed twice per procedure during the assembly of this batch.No quality notifications were written for this batch, nor for the associated assembly batch.
Event or Problem Description
It was reported that before use of the bd precisionglide needle that the needle is dirty.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8051694
• Report Number: 1911916-2018-00617
• Device Sequence Number: 1959374
• Product Code: FMI
• UDI-Device Identifier: 30382903051244
• UDI-Public: 30382903051244
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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: 06/30/2021
• Device Catalogue Number: 305124
• Device Lot Number: 6152940
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/10/2018
• 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