MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER LOK¿ SYRINGE WITH NEEDLE; PISTON SYRINGE

Catalog Number	309572
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd luer lok¿ syringes with needles were leaking when filled.There was no report of exposure, injury, or medical intervention noted.
Event or Problem Description
It was reported that the bd luer lok¿ syringes with needles were leaking when filled.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
Three hundred sealed 3ml packaged syringes with needles were received and confirmed to be from batch #8010876 (p/n 309572).One box also contained 15 packaged 3ml syringes not manufactured in canaan.The syringes are 3ml needle product from exel.The 300 bd-samples were visually evaluated.The samples were received in three shelf cartons of 100 syringes.One box was taped closed, the tape appeared to be from manufacturing process.The second box was taped closed, the tape appeared to be applied over the manufacturing tape by the end user.The third box was taped closed with narrow scotch tape perpendicular to the manufacturing tape on the shelf box.All syringes were sealed no visual defects were observed.After the initial evaluation was performed the samples were removed from packaging for leak testing.See details below.300 bd-syringes tested per applicable procedure.Luer leakage test ¿ 300 syringes tested with zero defects observed.Barrel leakage test - 300 syringes tested.27 syringes found with leakage issues due to barrel damage.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.The root cause for the leakage confirmed is due to damaged syringe/barrel during the assembly process.It is possible that several syringes were damaged during the high speed assembly process.It is also possible that this failure was isolated during the batch run impacting only few seconds of the production.No corrective actions recommended based on the low defective rate identified as of today.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd luer lok¿ syringes with needles were leaking when filled.There was no report of exposure, injury, or medical intervention noted.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.

• Brand Name: BD LUER LOK¿ SYRINGE WITH NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7709450
• Report Number: 1213809-2018-00442
• Device Sequence Number: 16397873
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2018

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: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 309572
• Device Lot Number: 8010876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/02/2018; 07/02/2018
• Initial Report FDA Received Date: 07/22/2018
• Supplement Report FDA Received Date: 08/10/2018; 09/17/2018
• 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