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	10/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted, explanted date: device was not explanted, occupation: facility administrator.The actual device was not available for evaluation; however, unused same lot samples are available and are in transit.Based on the results of our investigation, the root cause of the complaint is due to the improper usage of the device.As stated on the additional information, the safety needle was activated using three methods of activation.Among the three methods, it is likely that the incorrect method was used, resulting in the needle stick.According to the ifu of sg2 needles, activation must be performed on a hard and flat surface in a quick and firm motion.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.We have received thirty-three (33) complaints covering fy20 to october 24, 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.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.Therefore, we advise to follow the instructions for use (ifu) for the proper usage of the sg2 needle indicated on the unit box in which warnings to prevent needle stick, cautions, and precautions are also included.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.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).
Event or Problem Description
The user facility reported that a fingerstick was incurred resulting from the inferior safety function.It takes an exceptional amount of force to properly click the safety in place.If one finger is used to deploy the safety as intended, it seems like it's in place but easily pops back open.Additional information was received on 12 oct 2022: the activation attempted was via finger/thumb and pushing against a hard surface.Procedure for the patient was patient injection.Patient was in stable condition.Health care professional blood was drawn, and preventative medication was taken by the associate.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide the unused sample return date in section d9, to update section h3, and to provide the completed investigation results.The actual sample was not returned for evaluation however three (3) unused pieces of the same lot were received.The samples were visually in good condition.The samples were visually confirmed free from defects that will affect activation of safety sheath.There was no further confirmation on the received same lot sample since it has the same condition as the retention sample.

• 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: 15748958
• Report Number: 3003902955-2022-00051
• Device Sequence Number: 6317380
• Product Code: MEG
• UDI-Device Identifier: 30612479178855
• UDI-Public: 30612479178855
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 102-N251S
• Device Lot Number: 210828B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2021
• 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 Sex: Unknown