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

Model Number	N/A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a needle had punctured the catheter involved.The event occurred intra-operative.There was no harm reported and no medical/surgical intervention required.The procedure outcome was unknown.The final patient impact was unknown.
Additional Manufacturer Narrative
Patient identifier: requested, unknown.Age & date of birth: requested, unknown.Patient sex: requested, unknown.Weight: requested, unknown.Ethnicity: requested, unknown.Race: requested, unknown.Expiration date: jun/2026.Implanted date - device was not implanted.Explanted date - device was not explanted.Device manufacture date: 21/07/25~21/07/28.Occupation: pharmacist/responsible for materiovigilance in the facility.One (1) terumo surflash i.V.Catheter was returned for investigation.When we closely observed the returned actual sample, the inner needle was confirmed to be sticking out at approximately 3mm away from the catheter tip.When closely verified five (5) pieces of retention samples of the reported lot under unopened package condition, no defective products, which inner needle sticked out form the catheter, were observed.The concerned product is continuously produced by fully automated machine, wherein an inner needle and a catheter are assembled in one motion.Furthermore, the tip of every assembly is being checked by special digital camera after inner needle and catheter are assembled.In case of any defects, such as tip-deformation, everted catheter or catheter tip occlusion occurred when assembled, 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 in the inspection machine and automatic reject system were recorded.The results of the quality inspection, which is periodically conducted, recorded no defective product, which has deformation in catheter tip.Furthermore, no similar incidents were reported from other facilities.The manufacture inspection records were thoroughly checked with focusing on the possibility that a defect may have occurred in our manufacture process, especially in the assembly process of inner needle and catheter.However, we were not able to identify the specific root cause since no irregularities were found.Relevant ifu reference: "do not attempt to re-insert a partially or a completely withdrawn needle." 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).

• 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: 15594100
• Report Number: 9681835-2022-00028
• Device Sequence Number: 19398960
• Product Code: FOZ
• UDI-Device Identifier: 34987350743535
• UDI-Public: 34987350743535
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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*FF2419
• Device Lot Number: 210724A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/13/2022
• 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