MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD® PLASTIC NRFIT¿ SYRINGE; PISTON SYRINGE

Catalog Number	400051
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.H.3.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 that the bd® plastic nrfit¿ syringe had scale marking issues.The following was received from the initial reporter: the customer mentioned that during testing of the device he and his colleagues found it difficult to read the graduated marks on the barrel of the syringe against the background of the plunger tip when aspirating small volumes of anaesthesia medication.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4)- follow up mdr for device evaluation.It was reported it was difficult to read the graduated marks on the barrel of the syringe.As a sample was not returned, a thorough sample evaluation could not be performed.A physical sample is required for a more thorough evaluation and potential root cause determination.A device history record review was completed for provided material number 400051, lot 0083149.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Lot 0083149 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Since no samples displaying the reported condition were received corrective actions are not necessary.We appreciate you taking the time to bring this observation to our attention.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.

• Brand Name: BD® PLASTIC NRFIT¿ SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17916849
• Report Number: 1213809-2023-01125
• Device Sequence Number: 16886812
• Product Code: FMF
• UDI-Device Identifier: 00382904000516
• UDI-Public: (01)00382904000516
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: SP
• PMA/510(K) Number: K192538
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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 Catalogue Number: 400051
• Device Lot Number: 0083149
• 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: 09/27/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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