MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number N/A

Device Problem Break (1069)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The user facility reported that the patient gave himself the injection and the involved needle broke off when he was injecting it and the liquid leaked out on the floor.The event occurred intra-operative.No harm reported.Potential harm due to broken cannula.The patient was not injured during the event and medical/surgical intervention was not needed.

Manufacturer Narrative

D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device was not returned; therefore, details of the actual condition were unable to be determine.Retention samples were visually inspected and confirmed free from any tilted cannula, bent cannula, or damage on cannula that might lead to the complaint.A total of eight (b)(4) complaints were received from the previous two fiscal years to the present for the same issue where the cause was not identified related to our product and production process.Retention samples were subjected to simulation.The syringe with safety needle was punctured into the rubber cork.Manual cannula bending test was conducted wherein needle was bent 45° from left to right for 40 times.Result, the needle did not break even after 40x bending.The root cause of the complaint could not be identified to be related to our production or process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot and the retention samples met the required specifications.Our cannula is supplied with raw material that complies with iso 9626, particularly on stiffness and breakage.The retention samples were confirmed visually in good condition.Simulation was conducted on the samples wherein the needle did not break even after 40x bending which indicates that our needles have high resistance to breakage.We have a online and in-process visual inspection to check bent or damage to the cannula that might lead to a complaint.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 SURGUARD2 SAFETY HYPODERMIC NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• 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: 18500214
• MDR Text Key: 333131515
• Report Number: 3003902955-2023-00074
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 34806017512942
• UDI-Public: 34806017512942
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/11/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 10180094
• Device Lot Number: 220624B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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
• Patient Sex: Male