MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE, REGULAR BEVEL NEEDLE

Catalog Number	305924
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that medication leaked from a bd safetyglide¿, regular bevel needle.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Correction: the initial mdr reported the lot # as (01)00382903059249.This is not a valid lot # in our production system.Further inquiry of the customer indicates the actual lot # is unknown as the sample was contaminated and disposed of by the vaccinating nurse.Investigation summary: photo evaluation: two photos were received depicting one assembled 3ml syringe with safetyglide needle attached reported to be from unknown batch # (p/n 305294).The syringe appears to contain a clear liquid.The stopper is fully seated to the barrel roof - zero line position.The clear liquid can be observed behind the stopper around the plunger rod tip outside the fluid path of the syringe.Liquid can also be observed filling almost all of the space between the stopper ribs, indicating a leakage past stopper condition.Dhr review could not be performed due to unknown batch #.Investigation conclusion: based on the photo evaluation: confirmed: bd canaan was able to confirm the customer's indicated failure.Without a batch number and/or a physical sample, investigation cannot proceed any further and root cause cannot be determined.

• Brand Name: BD SAFETYGLIDE, REGULAR BEVEL NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7370402
• Report Number: 1213809-2018-00194
• Device Sequence Number: 2311803
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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 Catalogue Number: 305924
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 04/16/2018
• 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