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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problems Pain (1994); Phlebitis (2004)

Event Date 05/29/2023

Event Type  malfunction  

Event Description

The user facility reported that the head nurse was channeling the patient with a surflash intravenous catheter (18g).There were no problems inserting the involved device into the skin and returned, but when the needle was removed to begin inserting the catheter did not slip and the patient began to report pain.The attempts were unsuccessful and to stop the patient for being hurt, the catheter was removed.Another line was channeled with another surflash (20g gauge) which was the only one on hand, this second channeling was successful.Another vein had to be channeled with another rechanneled surflash.The patient is epileptic.The event occurred intra- operative.The patient got phlebitis in the punctured area.No treatment for phlebitis was performed, it was only recanalized to another site.A new catheter was used to recanalization.Another puncture was performed on other site.The final patient impact was stable.

Manufacturer Narrative

A1: patient identifier: confidential.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: expiration date: april 2026.D6a: implanted date - device was not implanted.D6b: explanted date - device was not explanted.H4: device manufacture date: 05/24/21-05/26/2021.One (1) catheter was returned as an actual sample for investigation.Upon microscopically observing the returned sample, the tip of catheter was confirmed to be deformed and have a wider tip end.When we microscopically observed the needle tips of our same lot retention samples (5pcs), no defective properties, such as everted catheter, physical deformation, or burrs, which may have deteriorated the penetration performance, were observed in the catheter/inner-needle tips.Polyethylene sheet with 50micron thickness and unused samples were prepared to check penetration resistance and measured.The results were shown within our internal standard.Penetration resistance of the inner needle tip was an average 8.5gf (7.5gf-10.9gf) & penetration resistance of the catheter tip was an average 18.6gf (16.4gf-22.1gf).The concerned product is continuously produced by automated machine, wherein products undergo a 100% inspection to check needle tips utilizing a dedicated digital camera after the inner needle and catheter are assembled.In case of any defects, such as tip-deformation, everted catheter or catheter tip occlusion occurred when being assembled, the inner needle tips should get protruded from the catheter, so those defects will be detected, and the system will automatically segregate from the line and reject these defects.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, such as catheter tip deformation.Furthermore, no similar incidents for the reported lot were received from other facilities.As aforementioned, our investigation was performed to confirm if there was a possibility that the tip deformation noted in the actual sample may have been occurred in our manufacture process.However, no anomalies were shown in our process.We were not able to identify the specific root cause of the reported issue since no anomalies were confirmed in our manufacture inspection records and the retention samples.Relevant instructions for use (ifu) reference: do not attempt to re-insert a partially or a completely withdrawn needle.Terumo medical products (tmc) (importer) registration no.(b)(6) is submitting this report on behalf of kofu factory of terumo corporation (manufacturer) registration no.9681835.

Manufacturer Narrative

E1: establishment address: (b)(6).This report is being submitted as follow-up no.1 to correct section e1 - establishment address.The initial report inadvertently had the incorrect country.

• Brand Name: TERUMO SURFLASH I.V. CATHETER
• Type of Device: 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 ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 17232711
• MDR Text Key: 318212571
• Report Number: 9681835-2023-00003
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 34987350747519
• UDI-Public: 34987350747519
• Combination Product (y/n): N
• Reporter Country Code: CV
• PMA/PMN Number: K991406
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SR*FF1832
• Device Lot Number: 210521E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 06/29/2023
• Supplement Dates FDA Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 48 KG