MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION HT SYRINGES WITH SAFETY HYPODERMIC NEEDLE AND SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number N/A

Device Problem Activation Problem (4042)

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

Event Type  malfunction  

Event Description

The user facility reported that the safety on the needle goes off to the side instead of straight down to cover the needle.An employee was stuck with the needle because the safety is not very good.(b)(6)2023: staff member was not activating against a hard surface without walking around with needle.This occurred after a successful patient injection of high dose flu vaccine.The safety went to the side of the needle and the needle broke off.Stuck inside the employees' finger.No testing was performed to determine bbp exposure.Needle sticks did not require additional treatment aside from first aid.Staff member condition was stable.

Manufacturer Narrative

D4: catalog number: potential product codes: 102-sn3c2558s, 102-sn3c2558s, 102-sn3c2558s, & 102-n251s.D4: lot number: potential lot numbers: 191008d, 200207d, 201022d, & 201211b.D4: expiration date: potential dates: 30-sep-2024, 30-sep-2025, 31-jan-2025 & 30-nov-2025.D4: udi: (b)(4).D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: mst.H4: device manufacture date: potential dates: 08-oct-2019, 07-feb-2020, 22-oct-2020 & 11-dec-2020.The actual device is not available for return, therefore the details of the actual condition of the sample as was unable to be determined.The retention samples were visually inspected and confirmed free from defects that will affect activation of the safety sheath such as missing tooth, tooth flash, short shot, flash on the sheath, over or under insertion collar to the hub, sheath-collar fitting, and damaged parts.The samples were further evaluated for the sheath activation and deactivation functional test wherein all samples passed.A total of (b)(4) 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 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 is due to the improper usage of the device.The safety needle was not activated against a hard surface, as stated in the additional information.According to the ifu of mckesson, activation must be performed on a hard and flat surface in a quick and firm motion.A review of the product's lots history file revealed no issues that were encountered during the production of the reported lot and the retention samples met the required specifications.Series of visual in-process inspections to detect an abnormality on the sheath that may lead to a problem during sheath activation.The molding condition of the components critical to the safety activation of the product is routinely checked to ensure that no defects will be encountered that will lead to sheath activation problems and needle sticks.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Therefore, we advise following the instructions for use (ifu) for the proper use of the mckesson safety needles as indicated on the unit box, which also includes needle stick warnings, cautions, and precautions.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

• Brand Name: HT SYRINGES WITH SAFETY HYPODERMIC NEEDLE AND 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: 18166442
• MDR Text Key: 328513153
• Report Number: 3003902955-2023-00063
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30612479179098
• UDI-Public: 30612479179098
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• 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: FLU VACCINE