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

Catalog Number	300866
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd syringe 60ml e/t, the device experienced a defective stopper.The following information was provided by the initial reporter.The customer stated: distorted stopper.
Additional Manufacturer Narrative
Investigation summary : one photo was provided to our quality team for investigation.The product was visually inspected and the stopper was verified to be incorrectly assembled, partially detached from the plunger rod.There are no other visible defects observed that could have contributed to the issue.A device history review was performed for lot 2105010, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.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.While we could not identify a direct issue, it is possible this incident occurred as a result of improper alignment of the plunger/stopper to the barrel during assembly.A camera system is used in the assembly machine to detect missing or improperly assembled stoppers.There were no incidents documented related to any failures with the detection system, therefore we cannot identify why the impacted sample was not discarded.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.
Additional Manufacturer Narrative
Investigation summary : one photo was provided to our quality team for investigation.The product was visually inspected and the stopper was verified to be incorrectly assembled, partially detached from the plunger rod.There are no other visible defects observed that could have contributed to the issue.A device history review was performed for lot 2105010, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.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.While we could not identify a direct issue, it is possible this incident occurred as a result of improper alignment of the plunger/stopper to the barrel during assembly.A camera system is used in the assembly machine to detect missing or improperly assembled stoppers.There were no incidents documented related to any failures with the detection system, therefore we cannot identify why the impacted sample was not discarded.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported when using the bd syringe 60ml e/t, the device experienced a defective stopper.The following information was provided by the initial reporter.The customer stated: distorted stopper.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13387301
• Report Number: 3003152976-2022-00034
• Device Sequence Number: 4999465
• Product Code: FMF
• UDI-Device Identifier: 00382903008667
• UDI-Public: 00382903008667
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K110771
• 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): 01/18/2022

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 Catalogue Number: 300866
• Device Lot Number: 2105010
• 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: 01/11/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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