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

Model Number N/A

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/30/2022

Event Type  malfunction  

Event Description

The user facility reported that a staff member incurred a needle stick while using the involved needle.The product was reported to be more difficult to fully set the safety lock feature and that they are not as sturdy as the sliding safety they are used to.The event occurred intra-procedure.There was no blood loss.The patient was not injured, and medical or surgical intervention was not required.Additional information was received on 12 may 2022: it was reported that the hinged safety did not seem to be as sturdy as others.The safety is unsteady to close with your finger.When they are trying to close, they push down against a hard surface and the entire needle and safety bend.They think the safety is fully engaged however it's not.Additional information was received on 14 may 2022: the staff member was in stable condition.The needle stick protocol was followed by the account.All source patient bloodwork was negative.No prophylactic treatment was necessary.

Manufacturer Narrative

Catalog number: potential product codes - 102-n251s & 102-n25105s.Lot number: potential lots - 210717b & 210125b.Expiration date: potential dates - june 30, 2026 & december 31, 2025.Udi: potential udi's - (b)(4) and (b)(4).D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.Device manufacture date: potential dates - july 17, 2021 & january 25, 2021.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.Retention samples were visually confirmed free from defects that will affect activation of safety sheath and passed 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 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.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.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo ((b)(4)) corporation (manufacturer) registration no.3003902955.

• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14645005
• MDR Text Key: 301578292
• Report Number: 3003902955-2022-00016
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• 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: 05/12/2022
• 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
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White