MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 23X1 RB; PISTON SYRINGE

Model Number	309571
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
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 the syringe 3ml ll w/ndl 23x1 rb experienced a molding defect -sharp protrusions which was noted prior to use.The following information was provided by the initial reporter: material no: 309571 batch no: 9189738.Per complaint description: we received a voicemail stating that product 309571, had extra piece of plastic.
Event or Problem Description
It was reported that the syringe 3ml ll w/ndl 23x1 rb experienced a molding defect -sharp protrusions which was noted prior to use.The following information was provided by the initial reporter: material no: 309571 batch no: 9189738.Per complaint description: we received a voicemail stating that product 309571, had extra piece of plastic.
Additional Manufacturer Narrative
H.6.Investigation summary one loose 3ml syringe with needle attached was received and evaluated.It was observed there was epoxy extending onto the cannula and on the outside of the hub, which was rejectable per product specification.No visual defects were observed with the syringe.Potential root cause for the excess epoxy defect is associated with the needle manufacturing process.The samples were forwarded to the needle manufacturing site for evaluation and potential root cause determination.One sample was received.It is a 3ml syringe with a needle assembly connected to it.The syringe was inspected under the microscope; no pieces of plastic was observed in the syringe; only droplets of a solution.The needle assembly was also inspected.The plastic hub has a white epoxy drip over.No other defect was observed.Probable root cause : needle in process line assembly.The plastic hub is placed under the cannulator then the needle is positioned and assembled to the plastic hub adding the silicone to fix it after that a plastic hub is assembled.For the epoxy drip over, a jam at the cannulator could have happened and not detected in the next processes.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.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.H3 other text : see section h.10.

• Brand Name: SYRINGE 3ML LL W/NDL 23X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9451650
• Report Number: 1213809-2019-01255
• Device Sequence Number: 2923524
• Product Code: FMF
• UDI-Device Identifier: 30382903095712
• UDI-Public: 30382903095712
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/05/2020

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: 06/30/2024
• Device Model Number: 309571
• Device Catalogue Number: 309571
• Device Lot Number: 9189738
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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