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

Model Number N/A

Device Problem Short Fill (1575)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

Implanted date: no patient involvement.Explanted date: no patient involvement.Initial reporter health professional: health professional.Initial reporter occupation: commercial manager hc.The actual sample was not available for evaluation hence we could not determine the details of its actual condition.The result of the investigation confirmed that the aspirated volume capacity is within the requirement of 48ml to 52ml.Although, there was an improvement from the previous graduation scale length measuring 73mm, against the iso 7886-1 specification of 75mm.The graduation scale was expanded to 76.5mm.The modification still complies with the graduation capacity of 4% or equivalent to 48ml to 52ml, hence the improvement was implemented.Based on the details of the complaint, an investigation was performed, and the result showed that the terumo syringe weighs 51.7grams which is also equivalent to 51.7ml.This manifests that the syringe is still within the specification of 48-52ml.The risk management file was checked and causes related to the product design of the syringe were confirmed through the evaluation of the retention sample.All samples showed passed results; this suggests that the risk control measure is taken and implemented to reduce the risk related to an inaccurate graduation scale.Verification of the retention sample showed that the expelled volume capacity for the nominal scale is within the specification.A similar result was observed during the simulation (aspiration of 50ml liquid).To further improve the nominal capacity, the existing graduation scale length will be modified to 75mm.Based on the previous modification proposal, the 75mm graduation scale length will give a close value of 50ml graduated capacity.The target implementation of this improvement will be on february 2023.We have received six (6) complaints covering fy20 to fy22 (b)(6) 2022 related to this issue where the cause was not identified related to our product or production process.We have a series of inspections from the molding process to outgoing process to check ig, plunger, and barrel conditions.All samples showed passed results.Terumo medical products (tmp) (importer) registration no: (b)(4) is submitting this report on behalf of terumo (b)(4) corporation (manufacturer) registration no: (b)(4).

Event Description

It was reported that during the production of the cytostatic regimens for patients, the production technicians discovered that they were unable to get the full amount of liquid out of vials even though there was supposed to be enough in the vial, when the syringes with lot number: 220208h were used.An investigation was carried out, by means of weighing, they found out how much the sprayer left when the room was compared with the previous lot no.When they drew up 50ml of sterile water in the syringes with lot number: 220208h, showed that it held 51.7g.It was compared to the previous lot number: 211026h which held 49.9g of sterile water when they drew up 50ml.There was a difference of 1.8g, which amounts to almost 2 ml.(density sterile water 1 g/ml).There was no patient involvement.

• Brand Name: TERUMO SYRINGE WITHOUT NEEDLE
• Type of Device: 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 technopark; binan, laguna,, ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15741888
• MDR Text Key: 307621073
• Report Number: 3003902955-2022-00052
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K063613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• 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: SS+50L1
• Device Lot Number: 220208H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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