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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

The user facility reported that the involved catheter was fine at first however when it was removed the part that feeds into the vein portion broke off.The broken portion traveled to the lungs before it could be removed from the leg.The patient is currently stable.The event occurred intra-operative.No blood loss was reported.There is a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.The patient was not injured during the event and medical/surgical intervention was not needed.Additional information was received on 14 feb 2024: the catheter was placed with no issue for a neuter on a canine.The catheter was in use for approximately three (3) hours with no noted leakage.During the removal of the catheter, it was noted that when the bandage was cut off at the iv site, the catheter was cut, and slipped into vein before it could be retrieved.The dog was taken to an emergency vet hospital, where it was confirmed through testing the iv catheter had traveled to the lung.The canine was not showing any signs of an adverse reaction and will likely not be affected by the catheter fragment.The canine has been released home and is showing no signs of an adverse effect.The hub portion of the catheter was disposed prior to the reporter's awareness.It is possible that the catheter was cut by the person removing the bandage.

Manufacturer Narrative

A2: date of birth: requested, not provided.A3a: sex: requested, not provided.A3b: gender: n/a a4: weight: requested, not provided.A5: ethnicity: not provided for animal use.A6: race: not provided for animal use.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: requested, unknown.E3: occupation: (b)(6).The actual sample was discarded & not available for evaluation, therefore, the details of its actual condition could not be determined 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 (test is in reference to iso 10555-1).Results were all passed against our specification of >7.845n.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.(b)(4).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.There were no reported issues with the product when it was inserted into the vein or during the 3-hour period it was used, indicating that the device worked properly.Based on the additional information, it is most likely that the catheter tube was accidentally cut while removing the surgical tape to which the catheter tube was adhered.We also have 2 stages of visual inspection which cover the overall condition of the product.Defects that might cause catheter breakage are detected during these processes.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

• 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: 18862876
• MDR Text Key: 337808842
• Report Number: 3003902955-2024-00004
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2024

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: 220707SF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2022
• 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: 24 MO