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 Problem Foreign Body In Patient (2687)

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

Ethnicity: patient is an animal.Race: patient is an animal.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: tech.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Retention samples were visually checked and confirmed free from a crack, pinhole, scratch, bent, or dent on the catheter tube.The retention samples were subjected to catheter tube and catheter hub fitting force wherein the expected result is that either the catheter tube will be removed/separated from the catheter hub, or the catheter tube will break during the test (test is in reference to iso 10555-1).Results were all passed against our specification of >7.845n.We have received twenty-seven (27) complaints covering fy20 to fy22 ((b)(6) 2023), from the same issue where the cause was not identified as related to our product or production process.There is no evidence that there was a pre-existing defect with the device related to either the materials or the manufacturing process.Verification of retention samples showed no related defects on the catheter tube that would lead to either catheter tube breakage or a detached catheter tube from the hub and passed the catheter tube and catheter hub fitting force test.Further evaluation of the tensile strength of our catheter tube was conducted through manual pulling and bending tests using resistance breakage tester (in reference to the previous catheter breakage complaints).The catheter tube elongated, and an evident dent was observed however, no breakage or holes were noted on the catheter tube.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that upon removal half of the plastic part didn't come out of the patient's vein.The plastic part of the catheter didn't come out.The event occurred post treatment.The patient was not injured during the event and medical or surgical intervention was not required.The patient condition was stable.X-rays were taken on the leg and chest.Additional information was received on 18 jan 2023: the patient (dog) was having a routine dental procedure.The iv was placed approximately 5 hours.No leakage or difficulty introducing the iv was noted.The iv catheter was being removed, post procedure.When removing the bandage, only the proximal end of the catheter was present, and approximately ½ length of distal end was missing.The skin was palpated to see if it could be located, then x-rays were taken of the leg and chest with no visual of the catheter located.It was stated that the catheter was not found and are not certain that the other portion went into the dog, but they could not find it.The dog was well and stable, post procedure and was released approximately 2:30 pm of the procedure.A follow was conducted the next morning that the dog rested well and was eating, with no evident health issues.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to update section d9, section h3 and to provide the completed investigation results.In the initial report it was reported the actual sample was available, however the actual sample is no longer available therefore, an evaluation of the actual device was unable to be conducted.As informed through the additional information, the involved device was inserted and in place on the patient for five (5) hours without any reported issues until the time it was removed which indicates that the device performed properly.It is most likely that the damage occurred during the removal process.

• 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: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16369471
• MDR Text Key: 309504053
• Report Number: 3003902955-2023-00006
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SROX2225V
• Device Lot Number: 220219SB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2022
• 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 Age: 9 YR
• Patient Sex: Male
• Patient Weight: 18 KG