MAUDE Adverse Event Report: BECTON DICKINSON BD® LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	309626
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while health care provider was using bd® luer slip tip syringe with attached needle, they sustained a needle stick injury.The following was received by the initial reporter: details of complaint (reported issue): items received did not have safety glides.A staff member did get a needle stick injury because it wasn't a safety needle like it says on our website.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr (b)(4) - follow up mdr for device evaluation.Two samples of 1ml luer-slip syringes with 25x5/8¿ needles attached were received by bd.A quality engineer was able to review the samples from lot #3060191 regarding item #309626.Both samples were received in sealed packages with all applicable product information on the top web.Both samples had no defects.The conditions observed are acceptable per product specification.Based upon what was reported, the consumer assumes this to be a safetyglide needle.However, this product code and needle are not.The reported defect was not identified in the samples received.Therefore, no corrective action is required at this time.A device history record review was completed for provided batch number 3060191 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.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.H3 other text : see h10 manufacture narrative.

• Brand Name: BD® LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17925881
• Report Number: 2243072-2023-01835
• Device Sequence Number: 14192351
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: (01)30382903096269
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/01/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 309626
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown