MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SYRINGE WITHOUT NEEDLE; SYRINGE, PISTON

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when taking chemotherapy drugs, the black rubber stopper was not fully sealed.Which resulted in leakage of the drug's solution.Chemotherapy drug exposure due to leakage puts healthcare at risk.The event occurred pre-treatment.The patient was not injured during the event and medical/surgical intervention was not required.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e1: phone number: requested, unknown e3: occupation: sales four pieces of actual samples were returned.The actual samples were confirmed to be contaminated with the chemotherapy drugs therefore the evaluation conducted was only limited to visual inspection due to the risk of exposure.The injection gaskets were properly attached to the plunger and free from any deformity.The retention samples were visually inspected and confirmed that the injection gasket (ig) was properly attached to the plunger and free from the deformity.The samples were evaluated for gasket fit force and stopper strength.All samples showed passed results.A total of one (3) complaints were received from the previous two fiscal years to the present for the same issue where the cause was not identified as related to our product or manufacturing process.The root cause of the complaint is not related to our product or process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot.The actual samples reveal no problems that could contribute to the reported complaint.An inspection system is in place that can detect and automatically remove faulty engagement (between ig and plunger) and a peeled injection gasket.Only products in good condition are supplied to the next process.We also conduct routine inspections to ensure the quality of our products.Terumo medical products (tmp) (importer) registration no.(b)(4).Is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

• Brand Name: TERUMO SYRINGE WITHOUT NEEDLE
• Common Device Name: SYRINGE, PISTON
• 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, binan ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17892627
• Report Number: 3003902955-2023-00052
• Device Sequence Number: 7760290
• Product Code: FMF
• UDI-Device Identifier: 34806017511426
• UDI-Public: 34806017511426
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K063613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SS-30L
• Device Lot Number: 230424G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 10/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADRIAMYCIN / DOXORUBICIN 10MG / 5ML
• Patient Sex: Unknown