MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The user facility reported that the problem observed with the involved needle was that it was too sharp (pointed).When the staff introduces the needle into the membrane of the drug vial, there is a flow of liquid around the needle, which exposes the staff to the oncology product (danger) and there is a loss of the drug which may cause additional costs.The event occurred pre-treatment.Additional information was received on 07 dec 2022: there was no patient involvement when the issue occurred.Patients' health was not impacted by this issue with the needle being too sharp.Additional information was received on 08 dec 2022: the medication vial (manf.) they are using with the needles, was that all drugs to be prepared for injection in a solution.The damage and the splash solution must be decontaminated on the fume hood therefore the possibility of being exposed to cytostatic drugs is high.

Manufacturer Narrative

Patient identifier: no patient involvement.Age & date of birth: no patient involvement.Patient sex: no patient involvement.Weight: no patient involvement.Ethnicity: no patient involvement.Race: no patient involvement.Date of event: fall 2022.Operator of device: staff.Implanted date: no patient involvement.Explanted date: no patient involvement.Phone number: requested, unknown.The actual sample was not available for evaluation hence we could not determine the details of its actual condition.The retention samples were visually inspected and confirmed free from any damage on the cannula tip that will lead to the complaint.The samples were also evaluated for the needle penetration test.All samples showed passed results.This is the first time a complaint was received related to leakage between the needle and vial rubber stopper from the period of fy2020 to fy2022.The retention samples were subjected to simulation.First, the needles were securely tightened to the syringe with a clockwise twisting motion until resistance was felt.Second, the needles were inserted into the keyhole port of the vial rubber stopper.Lastly, the sterile water was aspirated from the vial of medicine.Results, the puncture hole did not expand that will trigger the leakage.The needle was smoothly punctured with minimum penetration resistance during insertion.There was no leakage encountered between the needle and the vial rubber stopper during aspiration.The root cause of the complaint could not be identified to be related to our product or production process.Leakage can occur when the rubber vial stopper is damaged after being punctured, which can happen due to improper usage or a damaged needle tip.However, we have an automatic needle tip inspection system during the needle assembly that can detect damaged needle tip.We also have a visual in-process inspection wherein part of the check items are burr/bend point and tip damage.The lot history file revealed no nonconformity or irregularity related to the complaint.Before shipment, qc conducts visual and functional outgoing inspections to check the condition of assembled needles.All samples passed.(b)(4).

• Brand Name: TERUMO NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna, ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16046010
• MDR Text Key: 308471199
• Report Number: 3003902955-2022-00067
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: NN1838R
• Device Lot Number: 220603B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1