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

Catalog Number	305924
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter (described as a ¿greasy sticky substance¿) was found in a bd safetyglide, regular bevel needle.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: one open 3ml syringe without package was received by bd canaan from batch #unknown (p/n (b)(4).The sample was visually evaluated.The stopper was visibly very lightly moist from siliconization process, which is part of a normal manufacturing process.No droplets or excess silicone was observed on the stopper or barrel walls of the syringe.Dhr review for batch 4301879 (p/n (b)(4): manufacturing dates: 11/13/2014 to 11/14/2014.Batch quantity was 216,000.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 4301879 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Confirmed: bd was able to confirm the customer¿s indicated failure.Investigation conclusion: root cause undetermined.

• Brand Name: BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7366415
• Report Number: 1213809-2018-00167
• Device Sequence Number: 1710939
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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: 10/31/2019
• Device Catalogue Number: 305924
• Device Lot Number: 4301879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 03/27/2018
• 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