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	12/01/2018
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 contaminated.
Additional Manufacturer Narrative
Medical device lot #: 8238636; medical device expiration date: 2023-07-31; device manufacture date: 2018-08-26.
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 contaminated.
Additional Manufacturer Narrative
Investigation summary: two 10ml syringes with needles attached were received and evaluated.One syringe was inside a sealed blisterpack with scotch tape around it, confirmed to be from batch #8238636 (b)(4).No visual defects were observed in the package nor the product inside.One syringe was loose inside a biohazard plastic bag with no package.The barrel was observed to have embedded foreign matter in the luer collar.The embedded foreign matter was larger than level 3 in size and is rejectable per product specification furthermore, 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.Potential root cause for the embedded foreign matter defect is associated with the molding process.No corrective actions are necessary based on the defective rate identified.
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 contaminated.

• 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: 8161908
• Report Number: 1213809-2018-00907
• Device Sequence Number: 19553011
• Product Code: FMF
• UDI-Device Identifier: 30382903096443
• UDI-Public: 30382903096443
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,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: 07/31/2023
• Device Catalogue Number: 309644
• Device Lot Number: 8238636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/03/2018; 12/03/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 01/07/2019; 03/04/2019
• 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