MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN; SYRINGE AND NEEDLE

Catalog Number	309580
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2017
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 3 ml bd luer-lok" syringe with attached needle 18 g x 1 1/2 in appeared to have mold inside the sealed package.Found before use.No serious injury or medical intervention noted.
Additional Manufacturer Narrative
One box of sealed 3ml packages was received by bd canaan and confirmed to be from batch #6266512.One syringe was in a plastic bag and was observed to have black foreign matter inside the package.The package was sealed, the black foreign matter was observed on the exterior of the needle shield and a small amount on the plunger thumb rest.Where it came in contact with the inside of the package, the fm was smearing on to the package.The package was opened and a small amount of fm was swabbed using a clean piece of cotton swab to be evaluated under magnification.The foreign matter was identified as grease with metallic particles.This type of grease is present in the manufacturing equipment, such as the assembly machinery.Based on the sample evaluation bd canaan was able to confirm the customer's indicated failure.Based on the severity assigned to this complaint and the results of the complaint lot history check, capa is not required at this time.
Additional Manufacturer Narrative
Date received by manufacturer: should be 09/25/2017.

• Brand Name: 3 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 6979693
• Report Number: 1213809-2017-00185
• Device Sequence Number: 67560
• Product Code: FMF
• UDI-Device Identifier: 00382903095803
• UDI-Public: 00382903095803
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2018

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: Physician
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 309580
• Device Lot Number: 6266512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: 09/25/2017; 09/25/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 11/10/2017; 01/11/2018
• 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