MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE 60ML E/T; PISTON SYRINGE

Model Number	300866
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd syringe 60ml e/t , the device experienced stopper separation from the plunger.The following information was provided by the initial reporter.The customer stated: disconnect between stopper and plunger rod.
Additional Manufacturer Narrative
Investigation summary: no samples or photos received for investigation.A device history review was performed for reported lot 2007081, no deviations or non-conformance's were identified during the manufacturing process that could have contributed to this issue.In assembly stations of 50ls manufacturing lines there is a vision system to detect stoppers bad assembled or missing stopper.In case any is defective it is rejected automatically.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.According to information received, the root cause of the non-conformance is related with a misalignment of plunger-stopper-barrel in the assembly station, however since no sample was received, root cause of the event reported could not be confirmed.We appreciate you taking the time to bring this observation to our attention.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SYRINGE 60ML E/T
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12820005
• Report Number: 3003152976-2021-00759
• Device Sequence Number: 4957544
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2021

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: 06/30/2025
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2007081
• 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: 10/18/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2020
• 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
• Patient Sex: Unknown