MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305900
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 needle sftygld 22x1-1/2 rb cannula broke off from the hub.The following information was provided by the initial reporter: material no.: 305900 batch no.: 7212757.It was reported the needle broke off from the hub.
Additional Manufacturer Narrative
H.6.Investigation summary one photo of a loose safetyglide needle was received and evaluated.It was observed there was no safety shield present and the cannula was separated from the hub.It appeared there was insufficient epoxy on the cannula, which was reject per product specification.Potential root cause for the cannula separation defect is associated with the safetyglide needle assembly process.When the needle was assembled to the plastic hub no epoxy was applied; the needle was been hold by the safety mechanism.When the safety mechanism got activated the needle got loose.No corrective actions are necessary based on the defective rate identified.Batch 7212757 is considered in compliance with our product specification requirements.Furthermore, 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.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.
Event or Problem Description
It was reported that needle sftygld 22x1-1/2 rb cannula broke off from the hub.The following information was provided by the initial reporter: material no.: 305900 batch no.: 7212757 it was reported the needle broke off from the hub.

• Brand Name: NEEDLE SFTYGLD 22X1-1/2 RB
• 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: 9779369
• Report Number: 1213809-2020-00151
• Device Sequence Number: 19593335
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: 30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 03/27/2020

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: 07/31/2022
• Device Model Number: 305900
• Device Catalogue Number: 305900
• Device Lot Number: 7212757
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/27/2020
• 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