MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 5 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	309633
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Numbness (2415); Eye Irritation (4803)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported 5 ml bd luer-lok¿ syringe with attached needle was leaking.The following was received by the initial reporter: reported issue: leaking; (b)(6) 2023.On (b)(6) 2023 one of our medical assistants was drawing up lidocaine using the 5ml (b-d309577 syringe, 21g x 1.5", needle combo) when instead of drawing into the syringe some of the lidocaine came squirting out the side of the needle where the needle attaches to the syringe (green part).The needle was securely attached to the syringe.The lidocaine went into her eye requiring it to be flushed out.She had irritation and numbness to her eye and surrounding tissue for several hours after the incident.I promptly reported the incident to medline to bring awareness to a possible product defect.
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.
Additional Manufacturer Narrative
Pr 8990096 - follow up mdr for device evaluation.It was reported there was a leakage issue.As a sample was not returned, a thorough sample evaluation could not be performed.A physical sample is required for a more thorough evaluation and potential root cause determination.A device history record review was completed for provided material number 309633, lot 3060178.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Lot 3060178 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Since no samples displaying the reported condition were received corrective actions are not necessary.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.
Event or Problem Description
No additional information.

• Brand Name: 5 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17924814
• Report Number: 1213809-2023-01131
• Device Sequence Number: 12463702
• Product Code: FMF
• UDI-Device Identifier: 30382903096337
• UDI-Public: (01)30382903096337
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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?: Yes
• Operator of Device: Other
• Device Catalogue Number: 309633
• Device Lot Number: 3060178
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Other
• Patient Sex: Unknown