MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3ML BD LL SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one strip of top web from batch #1139988, a loose 3ml syringe (p/n 303401), and a vial access cannula were received.The samples were visually evaluated.There were no visible defects on the 3ml syringe.The vial access cannula was observed to have been snapped where the shaft meets the body of the component.It was unclear if the component was damaged prior to usage by the customer leading to the break, or if customer misuse contributed to the cannula snapping.The defect could not be confirmed to have originated at the manufacturing plant, therefore corrective actions are not necessary.Furthermore, 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.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.Investigation conclusion: the defect could not be confirmed to have originated at the manufacturing plant, therefore corrective actions are not necessary.
Event or Problem Description
It was reported that the 3ml bd ll syringe experienced a needle that broke.The following information was provided by the initial reporter: the syringe went completely perpendicular.

• Brand Name: 3ML BD LL SYRINGE
• 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: 12736637
• Report Number: 1213809-2021-00735
• Device Sequence Number: 17337038
• Product Code: FMI
• UDI-Device Identifier: 30382903034018
• UDI-Public: 30382903034018
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 10/29/2021

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 Expiration Date: 04/30/2026
• Device Model Number: 303401
• Device Catalogue Number: 303401
• Device Lot Number: 1139988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1