MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON PREVENT ® HT SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number	N/A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the needle involved seemed faulty.The staff has noticed that often, the needle doesn't correctly lock after use, even if it clicked, which lead to the thought of the needle being locked and covered, however was not.This has led to a needle stick injury and is a safety issue.Additional information received 21 nov 2022: there was no blood loss.The patient was in stable condition.Testing was performed due to the needle stick, a hep panel and hiv.The injection was completed as intended.The staff member activated the needle against a hard surface as indicated in instructions for use (ifu).
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: operations associate.The actual sample was not available.Only the printed top film of the actual sample was provided hence we could not determine the details of its actual condition.Retention samples were visually inspected and confirmed free from defects that will affect activation of 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, tilted cannula, and damaged parts.Retention samples were further evaluated for sheath activation and deactivation functional test wherein all samples passed.We have received thirty-five (35) complaints covering fy20 to fy22 (november 22, 2022) related to this 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 production process.The root cause of the complaint could not be identified to be related to our production or process.The actual sample was not available for our evaluation and the condition of the sample from the branch cannot be confirmed in the photo.Retention samples were visually confirmed free from defects that will affect the activation of the safety sheath and passed the evaluation for sheath activation and deactivation.Also, no irregularity was encountered during the simulation of manual sheath activation that may lead to the complaint.We have a 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 assure that no defects will be encountered that will lead to sheath activation problems.Similarly, the assembly status of the safety needle such as sheath collar fitting and damaged parts that will affect product function is being confirmed.Lot history file revealed no related nonconformity or irregularity that will lead to the complaint.Prior to shipment, qc conducts outgoing visual, sensory, and functional inspections to assure lots are of good quality.Terumo medical products (tmp) (importer) registration no: (b)(4) is submitting this report on behalf of terumo (b)(4) corporation (manufacturer) registration no: (b)(4).

• Brand Name: MCKESSON PREVENT ® HT SAFETY HYPODERMIC NEEDLE
• Common Device Name: 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: 15936614
• Report Number: 3003902955-2022-00062
• Device Sequence Number: 14967241
• Product Code: MEG
• UDI-Device Identifier: 30612479178886
• UDI-Public: 30612479178886
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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 Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 102-N25105S
• Device Lot Number: 210522B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic
• Patient Race: White