MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLASH I.V. CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: expiration date: may 29.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: unknown.H4: device manufacture date: 06/13/24 - 06/15/24.The reported event occurred when the products were used on dogs or cats.No sample was returned for investigation.Hence, our retention samples of the reported lot were utilized for investigation.Retention sample check: when we observed the catheter part of retention samples (5pc), no defective properties, such as burrs or deformation, which may have contributed to catheter damage, were observed.Manufacture inspection record check: the concerned product type is continuously produced by fully automated machine, and an inner needle and a catheter are assembled by one-time operation.Furthermore, for all the products of concerned product type, a tip of assembly is being checked by special digital camera after inner needle and catheter are assembled.In case of any defects, such as tip-deformation or catheter tip occlusion, those defects will be detected, and the system will automatically segregate them from the line and reject.The manufacture inspection records of the reported lot were reviewed.As a result, no defective properties, which may have contributed to the reported issue, were observed.Furthermore, no similar incidents were reported from other facilities.As there were no anomalies observed in our manufacture inspection records and the retention samples, we were unable to identify the root cause of reported issue.Terumo medical products (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of kofu factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the involved catheter split internally upon placement with the most recent set of 22g x 1" terumo surflash wingless catheters.No surgical intervention was required.The procedure was completed with another type of device.The patient impact was unknown.Additional information was received on 27jun2025: the catheter would not advance as it had split.It was removed from the patient with no long-term impact or intervention required.There was no blood loss.The user was able to successfully place a terumo surflo-w 22g winged catheter successfully in the patient with no issue.The products were used on dogs and cats.The affected samples have been discarded, and no photos were taken as it was during the placement in anesthetized patients; therefore, they were discarded and replaced.
Additional Manufacturer Narrative
H6: investigation conclusion - 4315 is based upon the evaluation of the user facility information and the actual sample not being returned; 67 is based upon functional testing of the retention sample.This report is being submitted as follow up no.1 to provide a correction to section d4: model #, h6: investigation conclusions, and add a statement to section h11.

• Brand Name: SURFLASH I.V. CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 22393957
• Report Number: 9681835-2025-00009
• Device Sequence Number: 9060582
• Product Code: FOZ
• UDI-Device Identifier: 34987350743597
• UDI-Public: 34987350743597
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K991406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: SR*FF2225
• Device Lot Number: 240614D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/18/2025
• 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