MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO WINGED INFUSION SET

Catalog Number	SV-25BLK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the needle detached from the butterfly surflo winged infusion set, and stayed in the patient's arm post infusion procedure.Additional information was received on 16oct2020.The patient was receiving end of life treatment in hospice care.The sv device was placed on (b)(6) 2020 for sub-q medication delivery at the left upper scapula.The patient was restless; however, the night nurse did not note anything unusual at bandage site.The needle was discovered to be missing on (b)(6) 2020, when the sub-q site was being discontinued.X-ray confirmed the needle to be 3.5cm from the site.They are not removing the needle since patient is at end of life, and removal would cause more harm than leaving it where it is.They confirmed the needle (steel) was not broken, however, had slipped cleanly out of the butterfly.

• Brand Name: SURFLO WINGED INFUSION SET
• Common Device Name: SURFLO WINGED INFUSION SET
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• MDR Report Key: 10823868
• Report Number: 2243441-2020-00059
• Device Sequence Number: 14392749
• Product Code: FPA
• UDI-Device Identifier: 34987350726224
• UDI-Public: 34987350726224
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2020
• Report Date (Section F): 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SV-25BLK
• Device Lot Number: 191215
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 42
• Date Report Sent to FDA: 11/11/2020