MAUDE Adverse Event Report: TERUMO MEDICAL PRODUCTS HANGZHOU WINGED INFUSION SET WITH PROTECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation - sr.Clinical risk advisor.The actual device was not returned for evaluation.Manufacture record shows no abnormity noted during assembly process.Release inspection record shows that the inspection results of the safety shield deflection angle and activation of safety device are qualified.Reserved sample was tested to check whether there is any abnormity with the safety device.The appearance of safety devices of reserved samples was visually inspected.Result, there is no abnormity with the appearance of safety devices of deserved samples.Next, was to confirm the angle of the safety shield.The purpose was to confirm whether the fallen of the safety shield resulted from its deflection.The method used was to insert the vein needle fully into the flute of the fixture with the shield leaning against the fixture with the shield leaning against the fixture as below picture, visually inspect that the shield is within the limit lines.Result, the angle of the safety shield did not deviate from specification.Then, the activation of safety shield was tested.Purpose was to check whether the safety device can be successfully activated.Method was to activate the safety device according to the product's ifu to visually check whether the safety device can be activated.Result, the safety device can be activated, and no abnormity was noted.Final was the simulation test.Purpose was to check whether the safety device can be activated when it is normally used.Method was to simulated use according to product's ifu to confirm whether the safety device can be normally activated.Result, the safety device can be successfully activated when simulated use according to ifu.We checked production records and final inspection records of product as per complaint and found no problem or abnormity; web also did related performance test for retention samples and result shows no defect or abnormity.There is no evidence that this event was related to a device defect or malfunction.The customer replied that they did not hear the click of safety device.So, we judge that the needle stick was caused due to the safety device was not properly activated according to ifu.(b)(4).
Event or Problem Description
The user facility reported that the nurse received a needle stick injury because the safety cover did not fully engage over the sharp end of the needle.The nurse reports that she often finds the safety cover on the product "finicky" and unreliable.This poses a safety risk for our staff.Received a voluntary health (b)(6) report, (b)(6) report number (b)(4).Additional information was received 25october2019: the nurse was tested based on their protocol.They will send an update if there is any serious negative impact.Additional information was received 29october2019: the customer described that "the safety cover did not fully engage over the sharp end of the needle." which occurred after the safety device was activated, the needle detached from safety cover, which caused the finger to be mistakenly stuck by the needle.The incident occurred after the blood draw, so post-treatment.

• Brand Name: WINGED INFUSION SET WITH PROTECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TERUMO MEDICAL PRODUCTS HANGZHOU; m4-9-5, hangzhou economic &; technological, development zon; hangzhou, 31001 8; CH 310018
• MDR Report Key: 9347623
• Report Number: 3004102031-2019-00003
• Device Sequence Number: 19516473
• Product Code: FPA
• UDI-Device Identifier: 06927675503961
• UDI-Public: 06927675503961
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: SV*S23BL
• Device Lot Number: 190322B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1