MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LUER-LOK GAMMA IRRADIATED; PISTON SYRINGE

Model Number	304406
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.Investigation summary: two photos and one 10ml syringe (p/n 304406) assembled to an injectate delivery system were received.The syringe was visually evaluated.Part of the barrel from the 1ml grad line to the tip was received broken off from the syringe.The broken piece of the barrel was observed to have its collar cracked around the base and the tip bent.A crack was also present from the zero line on the broken piece up to the last scale marking visible.Potential root cause for the cracked luer defect could not be confirmed based on the evidence provided.The syringe was used in an unknown assembly process after leaving the manufacturing site.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.
Event or Problem Description
It was reported that the syringe 10ml luer-lok gamma irradiated leaked from the damaged luer-lock tip and cracked barrel.The following information was provided by the initial reporter: "customer report of issue of "plunger was unable to be pulled" was not confirmed during evaluation, however, leakage was observed from co-set syringe tip area.Checkvalves of flothru housing functioned properly during priming using coset syringe from lab." "tip of returned syringe dimensionally passed iso standard.Leakage occurred from a crack between the tip luer lock and syringe barrel.Damage was also noticed from the threads of the luer lock.".

• Brand Name: SYRINGE 10ML LUER-LOK GAMMA IRRADIATED
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12007760
• Report Number: 1213809-2021-00428
• Device Sequence Number: 19914071
• Product Code: FMF
• UDI-Device Identifier: 50382903044066
• UDI-Public: 50382903044066
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2021

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: 304406
• Device Catalogue Number: 304406
• Device Lot Number: 8324556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1