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 Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: cavalier king charles mix puppy.A2: date of birth: requested, not provided.A3b: gender: n/a.A4: weight: 4.8 kgs.A5: ethnicity: not provided animal use.A6: race: not provided animal use.D4: udi: not applicable.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be sent once the investigation is complete.Retention samples were visually checked and confirmed free from any damage 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.The catheter tube is made up of radiopaque ethylene tetrafluoroethylene (etfe) and undergo incoming inspection which includes visual inspection and verification of certificate of analysis according to the material specification.A total of twenty-eight (28) complaints were received from the previous two fiscal years to the present for the same issue where the cause was not identified as related to our product or manufacturing process.Based on the result of the initial investigation, we are yet to identify the root cause of the complaint.Evaluation will be conducted once the actual sample is received.The catheter tube condition of our retention samples was visually good and passed the related functional tests.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lots.No corrective action is taken as of this time.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

Event Description

The user facility reported there was a part of the involved iv catheter still in the patient's leg about 3/4 inches up after the removal of the catheter.Estimated blood loss was less than 250cc.The event occurred post-operative.The reported event required medical or surgical intervention.Additional information was received on 19 mar 2024: the catheter has been confirmed to not be in the patient's leg.The catheter was retrieved by surgical intervention.A torniquet was placed high on the leg with the patient sedated, the surgeon opened the leg and surgically removed the piece.The patient had been hospitalized overnight for chocolate ingestion.There was no procedure, only fluid diuresis when the catheter broke.The iv catheter was removed prior to the patient leaving.The patient went home with a pressure wrap in place as the nurse did not realize that the whole catheter did not come out.The owner returned as the bleeding would not stop.The patient was stable.Additional information was received on 02 apr 2024: the catheter placement was successful with no complications.The iv catheter was in place approximately 22 hours.There was no resistance or difficulty observed when the catheter was removed.However, the patient was very wiggly.The immediate impact when the patient returned was that the bleeding would not stop.The leg was cut open, the piece was isolated within the vein.The vein had to be tied off to remove the broken piece and the vein is no longer functional.The patient is doing well.The leg was cut open, the piece was isolated within the vein.The vein had to be tied off to remove the broken piece and the vein is no longer functional.The current condition of the patient is doing well to their knowledge.Additional information was received on 12 apr 2024: there was only one procedure completed to remove the catheter portion from the vein.

Manufacturer Narrative

This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.The proximal hub and distal point of the iv catheter were received.The tube was viewed under magnification, and it was observed that the proximal hub was pressed.It was also observed that the distal point was flattened and scratched.Traces of dried medicine and blood were observed inside the needle hub (proximal hub) and tube (distal point).Both points of separation have a clean cut.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.Based on the evaluation results, it was confirmed that the points of separation of the proximal hub and distal point ends had a clean cut.It is most likely that the catheter tube was accidentally cut during the removal process.There were no reported issues with the product when it was inserted into the vein or during the 22-hour period it was used, indicating that the device worked properly.There is no evidence that there was a pre-existing defect with the device related to either the materials or the manufacturing process.A review of the product's lot history file revealed no issues that were encountered during the production of the reported lot.

• 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, binan ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 19131147
• MDR Text Key: 341413396
• Report Number: 3003902955-2024-00012
• 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: 04/17/2024

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 Model Number: N/A
• Device Catalogue Number: SROX2025V
• Device Lot Number: 230727SF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2023
• 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: 4 MO
• Patient Sex: Female
• Patient Weight: 5 KG