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

Model Number	300866
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the syringe 60ml e/t the stopper was defective/deformed.The following information was provided by the initial reporter.The customer stated: "the stopper is deformed.".
Additional Manufacturer Narrative
H6: investigation summary photo received for investigation, upon visual inspection it can be observed the plunger is not correctly assembled to the plunger.No molding or other defects have been noticed.A device history review was performed for lot 2003208, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Possible root cause of the non-conformance is related with a misalignment of plunger-stopper-barrel in the assembly station.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.H3 other text : see h10.
Event or Problem Description
It was reported when using the syringe 60ml e/t the stopper was defective/deformed.The following information was provided by the initial reporter.The customer stated: "the stopper is deformed.".

• Brand Name: 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
• MDR Report Key: 12425347
• Report Number: 3003152976-2021-00557
• Device Sequence Number: 14347215
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: 02/28/2025
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2003208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1