MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Activation Problem (4042)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: a couple weeks ago.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - rn investigation findings: is based upon the evaluation of user facility information; based on the retention samples.Based on the results of our investigation, the root cause of the complaint is due to the improper usage of the device.The complaint details state that the user attempted to activate the safety sheath using the method by thumb and incurred a needle stick.Our unit box indicates instruction for use (ifu) for the proper activation of the device using a one-handed technique method on a hard surface.The condition of the actual sample was not confirmed since it was not returned for evaluation.Retention samples were confirmed free from defects that will affect activation of safety sheath.Related functional testing such as sheath activation and deactivation were all passed.We have series of visual in-process inspection to detect abnormality on the sheath that may lead to problem during sheath activation.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 problem.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 shipment, qc conducts outgoing visual, sensory, and functional inspection to assure lots are in good quality.Therefore, we advise to follow the instructions for use (ifu) for the proper usage of sg2 needle indicated on the unit box in which warnings, cautions and precautions are also included.

Event Description

The user facility reported that the user was trying to activate the device with an unintended method by thumb, and experienced a needle stick.There was no patient injury/medical, or surgical intervention.No patient was impacted.Additional information was received on 09 october 2020: after aspirating the medication, the user then attempted to push the sheath closed with her thumb to activate, she was then "scratched" with the tip of the needle, as she stated her thumb "slid across the needle".It was stated that they aspirate medication with one needle, then change to a new needle for injection.This occurred prior to any patient procedure, during preparation of vial with medication.It was a minor scratch and no treatment was required.She stated she just applied a band-aid on the scratch since there was no risk of infectious disease.She stated she understands now, not to attempt activation with this product, except on hard surface with fingers behind the needle at all times.There was no patient involvement.There was no impact on the procedure.The user that incurred the needle stick did not require any medical treatment.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE 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: theresa mussaw ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 10754723
• MDR Text Key: 213653589
• Report Number: 3003902955-2020-00036
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30612479178763
• UDI-Public: 30612479178763
• 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: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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
• Device Lot Number: 191114A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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
• Treatment: ASPIRATION OF MEDICATION