MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number SR-OT1464C

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: patient is a (b)(6).Age & date of birth: patient is a (b)(6).Patient sex: patient is a (b)(6).Weight: patient is a (b)(6).Ethnicity: patient is a (b)(6).Race: patient is a (b)(6).Expiration date: june 2025.Udi: not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Name of reporter.Unknown.Occupation: unknown.Device manufacture date: 07/07/20 - 07/09/20.One catheter hub was returned for evaluation, no damage was observed when closely checked.Retention sample check: the retention samples (5pcs) of the reported lot were prepared and each of the breaking strength was measured, wherein all results were shown within the manufacturer specification.Manufacture inspection record check: the catheter tube and catheter hub of the i.V.Catheter are continuously assembled by the automated machine in the following processes: cut catheter tube into the predetermined length and heat catheter tube end by a heated pin to make tips trumpet-shape.Place a caulking pin on the trumpet-shaped catheter end.Insert a catheter tube with caulking pin into a catheter hub.Push a calking pin into a catheter hub, wherein hub inner surface and the caulking pin sandwich a catheter tube.There is 100% inspection to automatically check the position of caulking pin to verify if a catheter is properly connected.If defective caulking pin insertion was found during the process, the detected products are automatically trapped and automatically disposed.The manufacture inspection records for the reported lot number were traced back and reviewed, wherein no defective condition, which may have degraded the connection strength between catheter tube and catheter hub, such as abnormal detection accuracy of automatic inspection machine, was noted.Moreover, no similar report was received from other facilities.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The probable root cause was presumed that some stress was applied to the connection between the catheter tube and catheter hub, and as a result, the catheter was pulled out from the caulking pin.The exact cause of the reported event cannot be definitively determined based on the available information.This report is for the second device reported, for the first device reported see mdr 9681835-2021-00005.(b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of (b)(4) (manufacturer) registration no.(b)(4).

Event Description

The user facility reported catheter damage on the terumo surflo i.V.Catheter.The catheter root was broken and almost remained in the cow body, when the user attempted to place a catheter in the cow's neck.When the catheter was about to have been broken, the user held it by his/her hand and prevented the catheter from being lodged in the body.There was no patient injury, medical/surgical intervention required.The procedure outcome was unknown.There was no health hazard reported.

• Brand Name: SURFLO IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• MDR Report Key: 12364277
• MDR Text Key: 268037669
• Report Number: 9681835-2021-00006
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K891087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/25/2021

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 Catalogue Number: SR-OT1464C
• Device Lot Number: 200704J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/25/2021
• 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