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	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd safetyglide¿ shielding hypodermic needle contained foreign matter.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Additional information: an additional lot was added to the complaint.Medical device lot #: 5117797; medical device expiration date: 4/30/2020; device manufacture date: 4/27/2015.
Event or Problem Description
It was reported that bd safetyglide¿ shielding hypodermic needle contained foreign matter.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd safetyglide¿ shielding hypodermic needle contained foreign matter.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: two loose 3ml syringes were received in a biohazard bag along with an opened empty safetyglide package from batch #8064678 (p/n 305924).An additional 3ml syringe and a safetyglide needle were received in an opened package separate from the bag above, loose in a box.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.Investigation conclusion: the first two samples were visually evaluated for fluid presence.One syringe was observed to have minimal presence of silicone on the stopper, primarily around the edge.One syringe was observed to have comparatively more silicone lubrication presence on the stopper with slight covering visible on the top as well.However, no stringing nor pooling of silicone was observed.The amount observed was within the expected and acceptable range for this product per product specification.The additional syringe received was from batch #5117797 (p/n 305924).It is not clear whether this sample was sent as a comparison piece as no notes were present.A minimal amount of silicone was observed only around the edge of the stopper.The amount observed was within specification.Root cause description: no defects were found in any samples received.Rationale: silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.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¿ 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: 8060239
• Report Number: 1213809-2018-00802
• Device Sequence Number: 13851449
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2019

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: 04/30/2020
• Device Catalogue Number: 305924
• Device Lot Number: 5117797
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 11/02/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/15/2019; 02/26/2019
• 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