MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305924
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2019
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 vaccine leaked past the plunger and out the bottom of the bd safetyglide¿ shielding hypodermic needle's syringe will drawing up the medication.
Additional Manufacturer Narrative
Investigation summary: one photo and one physical sample depicted in the photo along with an empty blister pack were received and evaluated.The sample was a 3ml used syringe with a safetyglide needle attached, its safety shield activated.The syringe had medication residue in the fluid path as well as past the stopper, indicating leakage past stopper.The stopper appeared to be insecurely attached to the plunger rod.The plunger rod was carefully pulled back and the stopper was observed to be dragging in the barrel separating on one side from the plunger rod¿s tip, revealing damaged plunger rod crown.Part of the plunger rod¿s tip was missing where it attaches to the stopper.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 potential root cause for the leakage past stopper defect is due to the damage plunger rod which is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Batch 7093907 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that the vaccine leaked past the plunger and out the bottom of the bd safetyglide¿ shielding hypodermic needle's syringe will drawing up the medication.

• Brand Name: BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
• 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: 8354096
• Report Number: 1213809-2019-00239
• Device Sequence Number: 11162769
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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 Expiration Date: 03/31/2022
• Device Catalogue Number: 305924
• Device Lot Number: 7093907
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/25/2019
• 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