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

Model Number N/A

Device Problem Break (1069)

Patient Problems Death (1802); Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier - the patient is a (b)(6).Ethnicity - the patient is a (b)(6).Race - the patient is a (b)(6).Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: unknown.Occupation - office administrator.The actual device has not been returned for evaluation.Based on the results of our investigation, the root cause of the complaint could not be identified.Since actual sample was not returned for evaluation hence we could not determine the details of its actual condition.Verification of retention samples showed no related defects on catheter tube that would lead to catheter tube breakage.Moreover, samples passed the catheter tube and catheter hub fitting force test.We have 2 stages of 100% visual inspection.The first station covers the overall condition of the product.The second station covers inspection of catheter tip and needle tip condition and the distance between catheter tip and needle heel.Thus, defects on catheter tube such as scratch, hole, crack or partial cut can be detected during these processes.In addition, lot history file showed that no non-conformities or troubles related to the complaint was encountered.Furthermore, qc conducts visual inspection to check product quality prior shipment.No nonconformity related to the complaint was noted.A follow up report will be submitted once the investigation is complete.(b)(4).

Event Description

The user facility reported that upon removing the catheter, the lumen separated from the catheter and entered the animal's vein.They cut open the vein to retrieve it, however it was not successful and the pet died from too much blood loss and prolonged anesthesia.Additional information was received (b)(6) 2020: the veterinarian stated that he was able to retrieve and remove the catheter, but the animal was very sick, and did not survive from the additional blood loss and anesthesia.The catheter had been placed for two days, with no reported leakage.There was no leakage noted at the time of removal, but the catheter was noted to be cut at the time it was being removed.The doctor stated the patient was very sick, being treated for complications from diabetes.However, the dog had improved and was getting ready to be released to owners.The doctor stated there was about 2/3 in vein and 1/3 outside, so he estimated 13 of the length where the cut occurred.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.In the initial report it was reported that the sample was available, however the actual sample is not available for return.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: TERUMO SURFLO INTRAVENOUS CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: theresa mussaw ; 950 elkton blvd.; elkton, md ; 2837866718
• MDR Report Key: 9727047
• MDR Text Key: 204576907
• Report Number: 3003902955-2020-00008
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SROX2225V
• Device Lot Number: 190126SC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2019
• 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