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

Model Number N/A

Device Problem Activation Failure (3270)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

A2: date of birth: 1982.D4: lot number: requested, unknown.D4: expiration date: unknown due to unknown lot number.D4: udi: unknown due to unknown lot number.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: medical device qa specialist.H4: device manufacture date: unknown due to unknown lot number.The actual sample was not returned for evaluation.We have received thirty-nine (39) complaints covering fy20 to fy22 (march 13, 2023), with the same issue where the cause was not identified as related to our product or production process.Most of the problems are related to usage particularly due to improper activation (not activating on a hard and flat surface in a quick and firm motion).The root cause of the complaint could not be identified.The actual sample was not available for evaluation and no retention sample and records were verified since the lot number was unknown.We have not encountered difficulties or any irregularity during the simulation of the representative samples through manual sheath activation.A series of inspections are being performed during in-process and qc outgoing which check the condition of assembled needles.Only passed lot samples will be shipped for distribution.We advise following the instructions for use (ifu) indicated in the leaflet for the proper usage of sg2 safety needles in which warnings to prevent needle sticks, cautions, and precautions are also included.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the needle stick injury safety needle cover did not function as expected and fell away exposing the needle tip as a syringe and needle placed into the sharp's container.Two injections were given at the time the safety shield was successful on another device i but failed on one.The event happened post-treatment.The patient was not injured, medical or surgical intervention was not required.The injection had been discarded into a sharps container and is therefore not available to return.One patient was having two (2x) of 120mg injections.The nurse gave one dose, and the doctor gave another dose.Following administration, the nurse slid the needle cover over the needle, which seemed not as rigid as the other one.When she put it into the sharps container the needle cover fell away rather than locking in place.The plastic wasn't as sturdy as the other cover on the other injection.A needle stick injury occurred to the nurse when disposing the needle.

• 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 technopark; binan, laguna,, ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16633622
• MDR Text Key: 312508091
• Report Number: 3003902955-2023-00012
• Device Sequence Number: 1
• Product Code: MEG
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SG2+2525
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 120 MG INJECTIONS
• Patient Age: 41 YR