MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 20ML E/T; PISTON SYRINGE

Catalog Number	300613
Medical Device Problem Code	Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that syringe 20ml e/t had a resistance building up in the syringe.The following information was provided by the initial reporter: we have received several complaints from the clinic that the 20ml syringes from you are showing increased problems with our pumps and are repeatedly not working.We have checked everything possible and came to the conclusion that there is obviously a greater resistance building up in the syringe.

• Brand Name: SYRINGE 20ML 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: 12453304
• Report Number: 3003152976-2021-00593
• Device Sequence Number: 3936039
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: 00382903006137
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 08/30/2021

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 Catalogue Number: 300613
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1