MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303401
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd 3ml syringe with luer-lok tip with vial access cannula was damaged and the interlink disconnected from the mating component.The following information was provided by the initial reporter: " it was reported by the health professional that the needles are difficult to push through medication vials, does not aspirate all the medication, and does not allow for multiple doses.It was also reported that the needle bent and caused a needle stick injury to the user's hand.".

• Brand Name: BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA
• 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: 11951684
• Report Number: 1213809-2021-00404
• Device Sequence Number: 11034118
• Product Code: FMI
• UDI-Device Identifier: 30382903034018
• UDI-Public: 30382903034018
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• 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
• Report Date (Section B): 05/26/2021

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: Other
• Device Model Number: 303401
• Device Catalogue Number: 303401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1