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	01/26/2018
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 before use a bd safetyglide¿ syringe with needle malfunctioned as ¿the rubber stopper appeared cracked upon inspection before use.¿ there was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
Investigation results: one 3ml luer lok syringe in opened blisterpack for safetyglide combo pack was received by bd canaan for investigation (lot number #6334588, catalog # 305924).Based on visual examination of the returned sample, stopper was not seated properly over plunger rod.Further investigation was conducted and plunger rod tip appeared deformed/ damaged which resulted in what it appeared to be angled stopper.This is a confined condition as per product specification.Syringe was tested for leakage and no leakage was observed during drawing and expelling.Dhr review for batch 6334588 (p/n 305924): manufacturing dates: 11/18/2016 to 12/05/2016.Batch quantity was 216,000.Assembly records were reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 6334588 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.The review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.The plunger rod was likely caught in one of the transfer conveyors prior to the assembly process.This resulted in the damage observed and in turn in the stopper unable to be properly seated on the plunger rod.No capa is required.Product defect confirmed based on sample evaluation performed.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.

• 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: 7330936
• Report Number: 1213809-2018-00152
• Device Sequence Number: 478416
• 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): 04/10/2018

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 Expiration Date: 11/30/2021
• Device Catalogue Number: 305924
• Device Lot Number: 6334588
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 04/10/2018
• 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