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

Model Number N/A

Device Problem Activation Problem (4042)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

The user facility reported that the terumo surguard 2 hypodermic safety firmagon injection failed, and i received a needlestick injury at 11 am today.The safety guard was not attached properly and the part where the syringe connects to the needle broke the glass causing the needle to imbed in my finger.The event occurred post-treatment.The patient was not injured during the event and medical or surgical intervention was not required.

Manufacturer Narrative

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.E2: health professional: requested, unknown.E3: occupation: requested, unknown.H4: device manufacture date: unknown due to unknown lot number.The actual device was not returned; therefore, the condition of the actual sample was unable to be determined.Since the lot number was unknown, no evaluation was performed.We received forty-nine (49) complaints 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 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.Representative samples of sg2+2525 were subjected to simulation.Securely tightened the safety needle to the syringe with a clockwise twisting motion until resistance is felt.Activated the safety sheath on a hard and flat surface (in a quick and firm motion) using a one-handed technique until an audible click is heard.Checked the cannula engagement under the lock (sheath tooth).Result, the needle was fully engaged under the lock (sheath tooth) and no irregularity during activation was encountered that may lead to the complaint.The root cause of the complaint could not be identified.The actual sample is not available for evaluation and no retention sample and records were verified since the lot number is 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 quality control (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.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

• 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: 17263836
• MDR Text Key: 318853387
• Report Number: 3003902955-2023-00026
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• 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: 06/06/2023
• 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