MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 5ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303403
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
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 bd 5ml syringe with luer-lok tip with vial access cannula experienced difficult plunger movement during use.The following information was provided by the initial reporter: material no.303403, batch no.8057945.Doctor was trying to draw up medication and was experiencing difficulty when pulling on plunger rod.
Additional Manufacturer Narrative
H.6.Investigation: three 5ml syringe were received and evaluated.Two syringes were loose, and one was in a fully sealed blister pack with a vial access needle, confirmed to be from batch 8057945 (b)(4).The loose syringes were examined manually, and it appeared as if the plunger rods had more resistance than expected.The packaged syringe was opened, and the resistance was measured using a force gage.The force gage measurements verified the tested syringe was outside of the product specification and the difficult plunger rod movement was confirmed.Potential root cause for the difficult plunger rod movement defect is associated with the assembly process.The was most likely caused by insufficient silicone (lubricant) in the barrel.No corrective actions are necessary based on the defective rate identified.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.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd 5ml syringe with luer-lok tip with vial access cannula experienced difficult plunger movement during use.The following information was provided by the initial reporter: material no.303403 batch no.8057945 doctor was trying to draw up medication and was experiencing difficulty when pulling on plunger rod.

• Brand Name: BD 5ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8764533
• Report Number: 1213809-2019-00701
• Device Sequence Number: 2665792
• Product Code: FMI
• UDI-Device Identifier: 30382903034032
• UDI-Public: 30382903034032
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• 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): 08/08/2019

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: 303403
• Device Lot Number: 8057945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 08/08/2019
• 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