MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 23X1 RB MCK; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	192-N231S
Medical Device Problem Codes	Break (1069); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that a needle sftygld 23x1 rb mck had the safety mechanism fail and the cannula break during use.The following was reported by the initial reporter: "it was reported that the needle broke after the safety mechanism was engaged.Event description per attached email states: needle broke off once safety mechanism was engaged.The new prevent sg needle broke off from syringe once the safety mechanism was engaged.Customer has a full box and some of another box.".
Additional Manufacturer Narrative
Investigation summary one photo displaying a loose safetyglide needle assembly attached to an unknown syringe was received and evaluated.It was observed the cannula was detached from the hub and loose in the safety shield, which was rejectable per product specification.Potential root cause for needle separation from hub defect is associated with the needle supplier¿s manufacturing process.It could have happened that a jam occurred at the cannulator an not enough epoxy was applied to the needle- plastic needle hub joint.The defective rate could not be determined as a valid batch number was not provided.A device history review could not be completed as no batch number was provided.H3 other text : see h.10.
Event or Problem Description
It was reported that a needle sftygld 23x1 rb mck had the safety mechanism fail and the cannula break during use.The following was reported by the initial reporter: "it was reported that the needle broke after the safety mechanism was engaged event description per attached email states: needle broke off once safety mechanism was engaged the new prevent sg needle broke off from syringe once the safety mechanism was engaged.Customer has a full box and some of another box.".

• Brand Name: NEEDLE SFTYGLD 23X1 RB MCK
• 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: 11032785
• Report Number: 1213809-2020-00896
• Device Sequence Number: 1308055
• Product Code: FMI
• UDI-Device Identifier: 10612479248554
• UDI-Public: 10612479248554
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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 Model Number: 192-N231S
• Device Catalogue Number: 306610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1