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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the terumo surflash i.V.Catheter involved disengaged from its hub while in the patient's vein.The patient had exerted traction on the catheter.There was no patient injury/medical or surgical intervention required.No harm was reported.The event occurred intra-operative.
Additional Manufacturer Narrative
Patient identifier: requested, unknown.Patient age & date of birth: requested, unknown.Patient sex: requested, unknown.Patient weight: requested, unknown.Patient ethnicity: requested, unknown.Patient race: requested, unknown.Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Device manufacture date: unknown due to unknown lot number.The actual sample was not returned for investigation.Since the lot number was not provided, the manufacture inspection records for past five (5) years, which is equivalent to the lifetime of the product, were traced back and reviewed.As a result, no defective properties, which may have degraded the bonding strength between catheter and catheter hub, including abnormal accuracy of inspection system, were detected.The catheter tube and catheter hub of our i.V.Catheter are continuously assembled by the automated machine in the following process: i) cut catheter tube into the predetermined length and heat catheter tube end by a heated pin to make tips trumpet-shape; ii) place a caulking pin on the trumpet-shaped catheter end; iii) insert a catheter tube with caulking pin into a catheter hub.Iv) push a caulking pin into a catheter hub, wherein hub inner surface and the caulking pin sandwich a catheter tube; v) we have a 100% inspection to automatically check the position of caulking pin to verify if a catheter is properly connected.If defective insertion of caulking pin was found during the process, the detected products are trapped and disposed of automatically.Since no actual sample was available, we were unable to identify the root cause of the reported issue.No irregularities were found in our manufacturer inspection records.(b)(4).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The report is being submitted to provide additional information.One (1) actual sample was returned for investigation.Upon closely checking the returned sample, it was confirmed that the catheter tube was pulled out from the catheter hub.Upon further checking the catheter tube length, the catheter tube was confirmed to have been slightly extended, which implies pulling stress has been applied to the catheter tube.No irregular damage or deformation, which may have deteriorated the fitting strength, were observed at the connection between the catheter hub and catheter tube.The root cause of the reported issue is most likely that the excessive pulling stress has been applied to the connection between the catheter tube and the catheter hub and, due to such stress, the catheter tube has been eventually pulled out from the caulking pin.
Event or Problem Description
Additional information was received on 16 sep 2022: the catheter was removed.No blood loss was reported.There was no impact on the patient.

• 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: gina digioia ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 15334548
• Report Number: 9681835-2022-00025
• Device Sequence Number: 20555376
• Product Code: FOZ
• UDI-Device Identifier: 34987350743573
• UDI-Public: 34987350743573
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/01/2022

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: SR*FF2032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Weight: 55 KG