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

Catalog Number SR-OT1464C

Device Problem Material Separation (1562)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

Ethnicity - patient is an animal.Race - patient is an animal.Medical device expiration date - june 2026.Udi - not required for product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter name : unknown.Establishment address: (b)(6).Initial reporter occupation: veterinarian.Device manufacture date - 07/07/2021 ~ 07/10/2021.The actual sample was not available for investigation.However, seventy-nine (79) pieces of unused same lot samples were-returned for our investigation.Visual inspection revealed no anomalies, such as defective shape, scratch, or deformation, which may have contributed to catheter breakage, were noted in catheters and catheter hubs.The bonding strength between catheter tube and catheter hub was measured, wherein the results were shown within our specification.The catheter tube and catheter hub of our 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 tube end.Insert a catheter tube with caulking pin into a catheter hub.Push a caulking pin into a catheter hub, wherein hub inner surface and the caulking pin sandwich a catheter tube.We have 100% inspection to automatically check the position of caulking pin to verify if a catheter is properly connected.If defective insertion of caulking-pin was found during the process no.5 stated above, the detected products are trapped and disposed automatically.The manufacture inspection records of the reported lot number were traced back and reviewed, wherein no defective condition, which may have degraded the bonding 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.The probable root cause was presumed that some stress was applied to the connection between the catheter tube and catheter hub, which has consequently caused a broken catheter.However, we were not able to identify the specific root cause.(b)(4).

Event Description

The user facility reported that they encountered broken a catheter with the involved terumo surflo i.V.Catheter.The catheter was manually removed.There was no death, injury, or medical/surgical intervention required to prevent injury or blood loss.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
• 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: stephanie handy ; reg. no. 2243441; 950 elkton blvid; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13949153
• MDR Text Key: 298045591
• Report Number: 9681835-2022-00004
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K891087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: SR-OT1464C
• Device Lot Number: 210704J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2022
• Initial Date FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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