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

Model Number	N/A
Medical Device Problem Codes	Positioning Failure (1158); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional 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.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: patient safety specialist.The actual device was not returned for evaluation.As stated on the received additional information, the needle was not activated on a hard surface, it is likely that the sheath did not fully activate that have caused needle stick.It is stated on the instruction for use that the activation must be done on a hard and flat surface in a quick and firm motion.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 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 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.(b)(4) is submitting this report on behalf of terumo ((b)(4)) corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
Terumo medical received an fda medwatch report mw# (b)(4).The event description states: the hypodermic needle was used by a doctor who closed the safety shield.The needle was handed to the or tech and the safety shield was defective, causing the or tech to be stuck by the needle.Needle appeared closed but housing flipped back.Additional information was received on 17june2021: the patient was stable with no residual issues.The patient received on source patent testing due to the needle stick.The needle was not activated on a hard surface.The needle stick caused minor blood loss.The needle stick was cleansed, occupational health notified, source patient lab results evaluated.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE SAFETY HYPODERMIC NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• MDR Report Key: 12167035
• Report Number: 3003902955-2021-00037
• Device Sequence Number: 3782567
• Product Code: MEG
• UDI-Device Identifier: 30612479178671
• UDI-Public: 30612479178671
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 102-N21105S
• Device Lot Number: 200520B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1