MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS NEEDLE SFTYGLD 21X1 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305915
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
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 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 the safety mechanism on the needle sftygld 21x1 rb tw did not engage.The following information was provided by the initial reporter: "safety mechanism did not engage on the safety hypodermic needle.".
Additional Manufacturer Narrative
Correction: the catalog and lot numbers have been updated.The following fields have been corrected: d.2.Medical device catalog#: 305915.D.2.Medical device lot#: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the safety mechanism on the needle sftygld 21x1 rb tw did not engage.The following information was provided by the initial reporter: "safety mechanism did not engage on the safety hypodermic needle.".
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.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
It was reported that the safety mechanism on the needle sftygld 21x1 rb tw did not engage.The following information was provided by the initial reporter: "safety mechanism did not engage on the safety hypodermic needle".

• Brand Name: NEEDLE SFTYGLD 21X1 RB TW
• 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: 10946765
• Report Number: 1213809-2020-00872
• Device Sequence Number: 3043638
• Product Code: FMI
• UDI-Device Identifier: 30382903059158
• UDI-Public: 30382903059158
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/17/2020

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: Other
• Device Expiration Date: 01/31/2025
• Device Model Number: 305915
• Device Catalogue Number: 305915
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 12/17/2020
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/17/2020; 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1