MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLASH I.V. CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: patient is an animal.Ethnicity: patient is an animal.Race: patient is an animal.Expiration date: sep/2026 implanted date - device not implanted explanted date - device not explanted occupation: unknown.Device manufacture date: 10/19/21-10/21/21.(b)(4).The actual sample was not returned for investigation.Retention samples of the same lot (5pcs) were utilized for the investigation.When we closely observed the retention samples no defective properties, which may have adversely contributed to catheter breakage, were observed.The manufacture inspection records of the reported lot were reviewed.As a result, no defective properties such as broken catheter or scratched catheter, have been detected.Furthermore, no similar incidents have ever been reported from other facilities.We were unable to identify the root cause of reported issue as no irregularities were found in our retention samples or our manufacture inspection records.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 after treatment and upon removal, the involved surflash poly catheter broke off.The doctor was able to milk the device out.Meds were administered during treatment, so it did work during the procedure.There was no incision needed to remove the device.The animal was in stable condition.The procedure outcome was successful.There was no patient injury.There was no medical or surgical intervention required.No equipment or other devices were used with the involved device.The event occurred post-treatment.Additional information was received on (b)(6) 2022: the patient was a feline.The catheter was placed in the front right arm.Almost the full length of the catheter broke off, there was only a few mm from the connection to the port.Most of the catheter broke off into the patients arm when it was pulled out.There was no death.The doctor was able to slowly milk/push out the catheter.There was no blood loss.

• Brand Name: SURFLASH I.V. CATHETER
• Common Device Name: SURFLASH I.V. CATHETER
• 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 ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 15182047
• Report Number: 9681835-2022-00020
• Device Sequence Number: 17754302
• Product Code: FOZ
• UDI-Device Identifier: 34987350743597
• UDI-Public: 34987350743597
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K991406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/08/2022

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: 1SR*FF2225
• Device Lot Number: 211018D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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