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

Model Number	305918
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2020
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.(b)(4).
Event or Problem Description
It was reported that during use with a bd safetyglide¿ needle when attempting to engage the safety mechanism the needle came out of safety shield.The following information was provided by the initial reporter: it was reported that the nurse was drawing up medication out of a bottle and when she attempted to slide the safety mechanism, the needle popped out of the safety shield.
Event or Problem Description
It was reported that during use with a bd safetyglide¿ needle when attempting to engage the safety mechanism the needle came out of safety shield.The following information was provided by the initial reporter: it was reported that the nurse was drawing up medication out of a bottle and when she attempted slide the safety mechanism the needle popped out of the safety shield.
Additional Manufacturer Narrative
H.6.Investigation: two photos were received and evaluated.On photos depicted a safetyglide package with top web visible.The photo was of low resolution and details of the package, such as the batch #, could not be read.One photo depicted a safetyglide needle attached to a non-bd 10ml syringe filled with medication in an end-user's hand.The safety mechanism of the needle was observed to be activated and fully extended.The cannula was separated from the hub of the needle assembly.A small piece of presumably epoxy was observed near the base of the cannula where it previously attached to the hub.A potential root cause for the cannula separating from hub defect is associated with the needle manufacturing process.Bd columbus completed their evaluation and determined that after the needle is assembled to the plastic hub the epoxy is applied.It is possible the epoxy applicator got clogged and didn't apply enough epoxy leading to the defect.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.H3 other text : see h.10.

• Brand Name: BD SAFETYGLIDE 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: 10368963
• Report Number: 1213809-2020-00511
• Device Sequence Number: 11727366
• Product Code: FMI
• UDI-Device Identifier: 30382903059189
• UDI-Public: 30382903059189
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Date (Section B): 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 305918
• Device Catalogue Number: 305918
• Device Lot Number: 0023092
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/25/2020
• 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