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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when a terumo surflash i.V.Cannula 22gxl" was used to place an intravenous (iv) line, a part of the plastic catheter tip snapped away and remained in the patient's cephalic vein.This required a minor procedure to remove the part left.The planned procedure still went ahead albeit it was a slightly longer anesthetic than planned.The patient was fine.The event occurred intra-operative.Additional information was received on (b)(6) 2022: the patient was in for an ovario-hysterectomy.The patient had been pre-medicated, and the iv catheter was placed to induce anesthetic.The catheter was placed in was the right cephalic vein.The head vet then used a cephalic cut down procedure to expose the vein, locate the fragment of catheter, remove, and then suture the wound.An iv line was placed in the left cephalic instead with no issues.
Additional Manufacturer Narrative
Investigation findings - code 3252 is based upon the photo provided; code 213 is based upon evaluation of the factory-retained sample.Investigation conclusion - code 4310 is based upon the photo provided; code 67 is based upon evaluation of the factory-retained sample.No actual sample was returned for investigation.Instead, sample photos were provided.Upon closely checking the provided photo, the catheter fracture surface was confirmed to be flat and smooth, which suggests the possibility that the tube has been damaged by a sharp-edged tool.When we observed the catheter and inner needles of retention samples (5pcs), no defective properties, which may have contributed to broken catheter, were observed.The concerned product is constantly produced by fully automated process that includes the assembly of inner needle and catheter, fitting connection of those, cap and protector attachment, and labeling of individual packaging through to boxing process.After receiving the report, the entire manufacture facility was thoroughly checked.As a result, no area was confirmed where sharp-edged tool may contact to the reported fracture portion.Furthermore, our manufacture inspection records of the concerned lot were thoroughly checked, wherein no defective records, such as an issue that may have contributed for a broken catheter, was noted.Furthermore, no defective products, such as scratched catheter or broken catheter, had been detected in our sampling inspection conducted per lot.No similar reports were received from other facilities with respect to the reported lot number.Based on the appearance of fracture surface, it was presumed that the catheter tube was damaged by a sharp-edged tool and eventually broken.However, as no anomalies were observed in the manufacture inspection records and our retention samples, we were not able to identify the specific root cause for the reported broken catheter.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: 15644653
• Report Number: 9681835-2022-00030
• Device Sequence Number: 19422319
• Product Code: FOZ
• UDI-Device Identifier: 34987350743597
• UDI-Public: 34987350743597
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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*FF2225
• Device Lot Number: 210924D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/20/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown