MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE SAFETYLOK 3ML LL W/NDL 25X5/8; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	309592
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
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 needle hub separated from the syringe safetylok 3ml ll w/ndl 25x5/8 while removing the shield.The following information was provided by the initial reporter: "consumer reported, pharmacy refilled her prescription with the wrong syringes.Stated, she should have received a "retractable" syringe for her b-12 shots stated, the wrong syringes will leak when administering her shot and once, the needle hub separated when removing shield.".
Additional Manufacturer Narrative
Investigation summary: 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.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 the needle hub separated from the syringe safetylok 3ml ll w/ndl 25x5/8 while removing the shield.The following information was provided by the initial reporter: "consumer reported, pharmacy refilled her prescription with the wrong syringes.Stated, she should have received a "retractable" syringe for her b-12 shots stated, the wrong syringes will leak when administering her shot and once, the needle hub separated when removing shield.".

• Brand Name: SYRINGE SAFETYLOK 3ML LL W/NDL 25X5/8
• 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: 11091404
• Report Number: 1213809-2020-00928
• Device Sequence Number: 19635126
• Product Code: FMI
• UDI-Device Identifier: 30382903095927
• UDI-Public: 30382903095927
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: 309592
• Device Catalogue Number: 309592
• Device Lot Number: 8047707
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1