MAUDE Adverse Event Report: TERUMO MEDICAL PRODUCTS HANGZHOU PREVENT SAFETY WINGED INFUSION SET (PSS); SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned for evaluation.Therefore, the investigation was based on the user facility information, production records, and the reserve sample.Visual inspection revealed no anomalies.The sample was successfully activated and operated in simulation with no anomalies or defects found.Production records and ex-factory test records found no problem or abnormity.There is no evidence that this event was related to a device defect or malfunction.With no return of the actual device the exact cause of the reported event cannot be definitively determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported that the safety cover is hinged to the needle.The following information was provided by the user facility: it does not pop onto the needle to cover it easily; to be able to use the safety cover you have to turn it over, and in that process that hinge does not always work correctly and will cause the needle to flip back onto you; this is using a one handed procedure; when they are trying to activate it on a table, it has a cushioned top, so you have to push very hard to try to activate it into the safety shield; sometimes it does not stay in the shield, so that is what is meant by needle popping back; the needle does not spring back, it is not always in the safety shield as it should be after pushing down; this did not impact any infusion process with any patients during use; they have not had any needle sticks, due to the difficulty, they just felt it was awkward to use; there were no other devices or equipment used with the product.Additional information was received on august 2, 2017.This was the first box of the stated product that they have used.

• Brand Name: PREVENT SAFETY WINGED INFUSION SET (PSS)
• 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: 6813799
• Report Number: 3004102031-2017-00006
• Device Sequence Number: 10797321
• Product Code: FPA
• UDI-Device Identifier: 40612479204353
• UDI-Public: 40612479204353
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K031266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2017

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 4666
• Device Lot Number: 170208B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1