MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number SR-OT2232C

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Expiration date: unknown due to unknown lot number.Udi: udi number is not required for this product code.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date: unknown due to unknown lot number.The actual device was returned for evaluation.Visual inspection revealed that a part of the catheter was snapped off and the catheter length was found to be 8mm shorter than a normal product.The damaged portion was observed under a microscope.Inverted v-shape damage, in which inner-needle had possibly created while it was being punctured through the catheter, was observed.Furthermore, tensile stress was also observed on the catheter.Ifu states: "do not attempt to re-insert a partially or completely withdrawn needle." the production lot number was not provided by the user facility.The manufacture inspection records for the past five years were traced and reviewed, and no irregularity was observed.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that an object with a sharpened edge, such as the inner needle, contacted the catheter and created a scratch, which resulted in the catheter fracture after tensile stress was applied.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the surflo iv catheter was inserted at 12:00pm on the 13th, and that arterial blood had been monitored from the a line.When checked at 1:00am on the 14th, the monitor was not responding, even though the nurse moved the catheter.The catheter was fixed again, and the doctor removed it at 2:00am.At that time, the doctor found the tip of the catheter was separated.The location of the catheter fragment has been identified and the attempt to remove the fragment is ongoing.The specific location of the catheter fragment was confirmed through echography.The fragment remains in the peripheral blood vessel and there may be higher risk if it is removed, the patient condition is still being monitored.There were no other devices or equipment used with the reported product.

• Brand Name: SURFLO IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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 409-3 853; JA 409-3853
• Manufacturer Contact: theresa mussaw ; 950 elkton blvd; elkton, md ; 2837866718
• MDR Report Key: 10374468
• MDR Text Key: 202700800
• Report Number: 9681835-2020-00004
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/06/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: SR-OT2232C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/06/2020
• 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 Outcome(s): Other; Required Intervention