MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE; SYRINGE WITH NEEDLE

Catalog Number	309644
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/17/2018
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 a 10 ml bd luer-lok¿ syringe with 20 g x 1 in.Bd precisionglide¿ needle was covered with plastic shavings.
Additional Manufacturer Narrative
Investigation: one 10ml syringe with a shielded needle attached was received inside an opened blister package from batch #8192989 (p/n 309644).The sample was visually evaluated.The needle¿s cannula was observed to be covered in numerous white fiber foreign matter particles.The shield was carefully taken off.The white fibers were covering the entire length of the cannula from tip to hub as well as the inside of the shield.The fm was larger than level 3 in size.The amount of fm observed is rejectable per product specification.Additional investigation was performed on the returned sample which was received with the needle shield covering the needle.The needle shield was removed and it was observed that there is loose white plastic on the needle and in the needle shield.This is likely from the result of a needle shield that was found on the floor and accidentally placed in with the good parts instead of the waste parts.This needle shield then was shielded on a needle.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.
Event or Problem Description
It was reported that a 10 ml bd luer-lok¿ syringe with 20 g x 1 in.Bd precisionglide¿ needle was covered with plastic shavings.

• Brand Name: 10 ML BD LUER-LOK¿ SYRINGE WITH 20 G X 1 IN. BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8224195
• Report Number: 1213809-2018-00968
• Device Sequence Number: 10846351
• Product Code: FMF
• UDI-Device Identifier: 30382903096443
• UDI-Public: 30382903096443
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 06/30/2023
• Device Catalogue Number: 309644
• Device Lot Number: 8192989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/07/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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