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

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Vasculitis (2004)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date: oct/2025, implanted date - device was not implanted, explanted date - device was not explanted, device manufacture date: 11/17/20-11/20/20.(b)(4).One (1) terumo surflash i.V.Catheter was returned for investigation.When we microscopically checked one (1) provided actual sample, the catheter tip was confirmed to be partially deformed as everted.When we microscopically checked the needle tips of our retention samples (5pcs) with the reported lot number, no defective product, such as everted tip, deformation or burrs in the inner needle tubes and catheters, which may have adversely contributed to degrade the insertion performance, were noted.Next, polyethylene sheet with 50-micron thickness and unused samples were prepared to check penetration resistance and measured.Following values were observed within our specified internal standard, penetration resistance of inner needle tip: average 10.4gf (9.0gf.-12.6gf), penetration resistance of catheter tip: average 27.7gf (25.5gf-29.5gf).The concerned product was continuously produced by fully automated machine.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, the catheter will be found punctured by the inner needle, and therefore those defects will be detected.Consequently, 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 conducted per lot number, recorded no defective product, which had 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 at during our manufacture process.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." (b)(4).
Event or Problem Description
The user facility reported that after puncture with the catheter involved, the catheter was inserted in the patient's arm and resistance was generated.Phlebitis occurred in the area and the catheter was removed.The nurse examined the affected device and observed a damage in the distal part of the catheter.The event occurred intra-operative.The patient developed phlebitis in the punctured area.A new catheter was used, and the puncture procedure was performed in the other arm.The patient was in stable condition.

• 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: 15594111
• Report Number: 9681835-2022-00029
• Device Sequence Number: 14007027
• Product Code: FOZ
• UDI-Device Identifier: 34987350747519
• UDI-Public: 34987350747519
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Nurse
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SR*FF1832
• Device Lot Number: 201116E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Unknown
• Patient Weight: 49 KG