MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON PREVENT ® HT 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 involved safety needle was faulty and resulted in a needle stick injury.Blood work has been drawn for both the patient and staff.The event occurred intra-operative.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 28 sep 2023: the sheath malfunctioned.It appeared to be engaged however it was not.All labs related to the patient were negative.The staff's labs were all negative.

Manufacturer Narrative

E3: occupation: practice manager the actual device was not returned for evaluation, therefore the details of the actual condition of the sample were unable to be determine.Retention samples were visually inspected and confirmed free from defects that will affect activation of the safety sheaths such as missing tooth, tooth flash, short shot, flash on the sheath, over or under insertion collar to the hub, sheath-collar fitting, tilted cannula, and damaged parts.Retention samples were further evaluated for the sheath activation and deactivation functional test wherein all samples passed.A total of seventeen (17) complaints were received from the previous two fiscal years to the present for the same issue where most of the problems are related to usage particularly due to improper activation of the device (not activating on the hard and flat surface in a quick and firm motion).Based on the investigation of individual complaints there was no attributable cause noted related to our product and manufacturing process.Simulation through manual sheath activation was conducted on the retention samples.An audible click was heard indicating successful safety activation.The needle is fully engaged under the lock (sheath tooth) and no irregularity during and after activation was encountered that may lead to the complaint.The root cause of the complaint could not be identified to be related to our product or production process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot.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 sg2 needle 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.

Manufacturer Narrative

This report is being sent as follow-up no.1 to correct section h4.

• Brand Name: MCKESSON PREVENT ® HT 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: 17982171
• MDR Text Key: 326313952
• Report Number: 3003902955-2023-00055
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30612479178855
• UDI-Public: 30612479178855
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2023
• 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: 102-N251S
• Device Lot Number: 200822B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2020
• 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