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

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Event Description

The user facility reported that the nurse experienced a needlestick.The event occurred intra-procedure.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.

Manufacturer Narrative

Patient identifier: requested, not provided, age & date of birth: requested, not provided, patient sex: requested, not provided, weight: requested, not provided , ethnicity: requested, not provided, race: requested, not provided , date of event: requested, unknown, lot number: requested, unknown, expiration date: unknown due to unknown lot number , udi: unknown due to unknown lot number, implanted date: device was not implanted, explanted date: device was not explanted, occupation: mckesson medical surgical account manager, device manufacture date: unknown due to unknown lot number.The root cause of the problem could not be identified.The actual sample was not available for our evaluation hence we could not determine the condition of its actual condition.We have received eight (8) complaints covering fy20 to fy22 (september 20, 2022), related to this issue where the cause was not identified related to our product and production process since most of the problem occurred due to usage.Lot history file and retention samples were unable to confirm since the lot of this complaint is unknown.Instead, simulation through manual sheath activation was conducted on the current lot samples.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.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 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.Before shipment, qc conducts outgoing visual, sensory, and functional inspections to assure lots are of good quality.Only lots with passed results are allowed to be shipped.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.Terumo medical products (tmp) (importer) (b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) (b)(4).

• 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 technopark; binan, laguna,, ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15540613
• MDR Text Key: 303565166
• Report Number: 3003902955-2022-00041
• Device Sequence Number: 1
• Product Code: MEG
• 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
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• 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-N231S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2022
• 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