MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO WINGED INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Increase in Suction (1604); Suction Problem (2170)
Health Effect - Clinical Codes	Extravasation (1842); Rupture (2208)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: expiration date: nov 2026.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: technician supervisor.H4: device manufacture date: 22dec2023 - 24dec2023.No sample was returned for investigation.Our retention samples of the same lot were used for investigation.Retention sample check: upon checking each part of the samples (two pieces) including wing, tube, and female connector, no defective properties, which may have contributed to leakage, such as scratch or damage, were observed.In addition, no irregularities that would cause a vessel rupture, such as needle tip deformation, were observed.During our manufacturing process, we have a series of quality inspections, including visual inspection and leakage test, per lot.When we traced back and reviewed the product inspection records of the reported lot, there have been no detective products, such as defective air tightness or damage, recorded.Moreover, no similar report has been reported from other facilities for the reported lot.We were not able to identify the root cause of the reported issue, since no anomalies were observed in the retention samples and our manufacture inspection records.The number of occurrences was multiple.We were not able to obtain the specific number.Two (2) mdrs were logged to cover the multiple occurrences.This is related to the mdr 9681835-2025-00003.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of kofu factory of terumo corporation (manufacturer) registration no.9681835.
Event or Problem Description
The user facility reported that while drawing blood the kit sucked out too much blood causing the vessel to rupture.It did occur on multiple occasions with the same lot number different techs and different patients.The blood loss was less than 250cc.The reported event did result in patient injury and/or require medical or surgical intervention.Additional information was received on 26feb2025: since the patient was a feline, the blood loss was quite a small amount, roughly was likely 0.5ml and the vein was blown.

• Brand Name: SURFLO WINGED INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer (Section G): TERUMO CORPORATION, KOFU; reg. no. 9681835; 1727-1, tsuiji-arai; showa-cho, nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 21652888
• Report Number: 9681835-2025-00004
• Device Sequence Number: 18484741
• Product Code: FPA
• UDI-Device Identifier: 34987350726163
• UDI-Public: 34987350726163
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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 Model Number: N/A
• Device Catalogue Number: 3SV-21BLK
• Device Lot Number: 231222B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown