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
Additional Manufacturer Narrative
Expiration date: nov/2022; implanted date: device not implanted; explanted date: device not explanted; manufacture date: 12/14/19~12/19/19.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.(b)(4).
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.
Additional Manufacturer Narrative
The actual sample was returned for evaluation.The needle was confirmed to have been removed from the wing part, and no needle was received.Upon checking the glue mound at the connection part between needle tube and hub, the glue remained, and no irregularity was observed in the glue amount.Two retention samples were visually checked, wherein no irregularity including detachment of needle tube or the defect that may cause needle detachment was observed.The bonding strength between needle tube and hub was measured and the results for both samples were shown to have met the manufacturer's specification.A review of the manufactruing records of the product code/lot# combination was conducted with no findings.Furthermore, the sampling test results were reviewed and no irregularities related to the glue amount and bonding strength of the needle tube were detected.Based on the investigation, it is presumed that greater stress than allowable limit has been applied to the actual sample.However, the exact root cause was unable to be identified, since no irregularity was found in the manufacture inspection records and our retention samples.

• 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: 10823861
• Report Number: 9681835-2020-00006
• Device Sequence Number: 11501681
• Product Code: FPA
• UDI-Device Identifier: 34987350726224
• UDI-Public: 34987350726224
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K771204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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