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	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
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 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 safety mechanism failed to engage.This was discovered during use.The following information was provided by the initial reporter: material no.: 305900 batch no.: 9316337.It was reported the safety mechanism failed to engage and would only engage half way.Brought to my attention that bd safetyglide needle failed to safety mechanism engage.22# x 1 1/2 inch checked six of them, and had 50% of them fail to spring close.Took multiple attempts to get them engage, and sometimes started to engage, but only closing half way, a definite safety risk for needle stick.I tested other gauges and sizes, and did not find any other issues.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.
Event or Problem Description
It was reported that needle sftygld 22x1-1/2 rb safety mechanism failed to engage.This was discovered during use.The following information was provided by the initial reporter: material no.: 305900.Batch no.: 9316337.It was reported the safety mechanism failed to engage and would only engage half way.Brought to my attention that bd safetyglide needle failed to safety mechanism engage.22# x 1 1/2 inch checked six of them, and had 50% of them fail to spring close.Took multiple attempts to get them engage, and sometimes started to engage, but only closing half way, a definite safety risk for needle stick.I tested other gauges and sizes, and did not find any other issues.

• 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: 9717273
• Report Number: 1213809-2020-00100
• Device Sequence Number: 16911327
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: 30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/04/2020

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: 10/31/2024
• Device Model Number: 305900
• Device Catalogue Number: 305900
• Device Lot Number: 9316337
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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