MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 20X1 RB; PISTON SYRINGE

Catalog Number	309578
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9037866.Medical device expiration date: 2024-01-31.Device manufacture date: 2019-02-06.Medical device lot #: 9044707.Medical device expiration date: 2024-01-31.Device manufacture date: 2019-02-13.
Event or Problem Description
It was reported that a syringe 3ml ll w/ndl 20x1 rb experienced leakage past the stopper/plunger, while another experienced stopper deformation/damage.Both defects were noticed during use.The following information was provided by the initial reporter: material no: 309578, batch no: 9037866 & 9044707.Customer reported: rn was drawing up a dose and the syringe had a faulty rubber stopper.Began running out of syringe so we lost the dose.The nurses tell me this is the second faulty syringe is a few weeks so they are now really watching when they remove them from their sealed plastic.
Additional Manufacturer Narrative
H.6.Investigation summary: one loose 3ml syringe with needle attached was received and evaluated.It was observed the stopper was not correctly attached to the plunger rod.The insecure stopper condition was rejectable per product specification.Potential root cause for the insecure stopper defect is associated with the assembly process.This likely occurred due to a mistiming between the plunger rod and stopper dial.No corrective actions are necessary based on the defective rate identified.Batches 9037866 & 9044707 are considered in compliance with our product specification requirements.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.
Event or Problem Description
It was reported that a syringe 3ml ll w/ndl 20x1 rb experienced leakage past the stopper/plunger, while another experienced stopper deformation/damage.Both defects were noticed during use.The following information was provided by the initial reporter: material no: 309578 batch no: 9037866 & 9044707.Customer reported: rn was drawing up a dose and the syringe had a faulty rubber stopper.Began running out of syringe so we lost the dose.The nurses tell me this is the second faulty syringe is a few weeks so they are now really watching when they remove them from their sealed plastic.

• Brand Name: SYRINGE 3ML LL W/NDL 20X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9193878
• Report Number: 1213809-2019-01047
• Device Sequence Number: 19510244
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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 Catalogue Number: 309578
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/24/2019
• 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