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

Model Number 305198

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd precisionglide¿ needle had foreign matter on the syringe.This was discovered before use.The following information was provided by the initial reporter: in 2019, chief of the venous configuration center opened the 20ml syringe and found that the needle had white spots.

Event Description

It was reported that bd precisionglide¿ needle had foreign matter on the syringe.This was discovered before use.The following information was provided by the initial reporter: in 2019, chief of the venous configuration center opened the 20ml syringe and found that the needle had white spots.

Manufacturer Narrative

H.6.Investigation: one sample was received.Visual inspection was performed.The needle assembly came with the plastic shield.After removing it, five spots of epoxy on the needle were observed.The plastic hub is placed under the cannulator, then the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it.In this case it may have happened that a jam occurred, and the equipment dispensed epoxy before the part was moved to the next station and it was not detected in the next processes.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.H3 other text : see h.10.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9526401
• MDR Text Key: 193678174
• Report Number: 1911916-2019-01340
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903051985
• UDI-Public: 30382903051985
• Combination Product (y/n): N
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

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
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Model Number: 305198
• Device Catalogue Number: 305198
• Device Lot Number: 8250844
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other