MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL W/NDL 20X1 RB; PISTON SYRINGE

Catalog Number	309644
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: two photos and two loose 10ml syringes with attached needles (p/n 309644) were received.The samples were visually evaluated.Both sample's hubs were twisted nearly to the point of snapping.Each hub was twisted in the same location.The observed condition was non-conforming per product specification.Batch #0265079 is considered in compliance with our product specification requirements.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.Investigation conclusion: 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.Root cause description: potential root cause for the twisted hub defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Rationale: capa not required at this time.
Event or Problem Description
It was reported that syringe 10ml ll w/ndl 20x1 rb needle was damaged.The following information was provided by the initial reporter: it was reported that needle bent and stuck staff member while attempting to draw up medication.Customer response: did the staff member require any medical intervention? no.What was the date of the event? on (b)(6) 2021.

• Brand Name: SYRINGE 10ML LL W/NDL 20X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12194014
• Report Number: 1213809-2021-00497
• Device Sequence Number: 3802416
• Product Code: FMF
• UDI-Device Identifier: 00382903096442
• UDI-Public: 00382903096442
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2021

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: Other
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 309644
• Device Lot Number: 0265079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1