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

Model Number	309574
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/12/2020
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.(b)(4).
Event or Problem Description
It was reported that there were 2 "globs of white foreign matter found on needle prior to injection with a bd 3ml syringe luer-lok¿ tip with bd precision glide¿ needle." the following information was provided by the initial reporter: consumer found "2 globs of white stuff about halfway up the shaft of the needle" prior to injection into vial.He is a home user, his wife usually gives injections.".
Event or Problem Description
It was reported that there were 2 "globs of white foreign matter found on needle prior to injection with a bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle.The following information was provided by the initial reporter: consumer found "2 globs of white stuff about halfway up the shaft of the needle" prior to injection into vial.He is a home user, his wife usually gives injections.
Additional Manufacturer Narrative
Investigation: no photos or samples were received for evaluation.Since no samples displaying the reported condition were received a potential root cause could not be defined and no corrective actions are necessary at this time.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10119386
• Report Number: 1213809-2020-00372
• Device Sequence Number: 3867209
• Product Code: FMF
• UDI-Device Identifier: 30382903095743
• UDI-Public: 30382903095743
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 309574
• Device Catalogue Number: 309574
• Device Lot Number: 9025616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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