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 12/05/2023

Event Type  malfunction  

Event Description

The user facility reported that a technician was using the involved sur-vet sur-flo catheter during a feline neuter.When removing the catheter, it snapped.So, the flexible catheter tip remained lodged in the patient when we went to pull the catheter out.Therefore, post x-rays were done which were not visible.The catheter tip was broken and stuck within the patient.The tape was all intact.The catheter is completely separated from the actual body catheter that was pulled out.The event occurred intra-operative.Additional information was received on 03 jan 2024: the catheter was placed approximately 45 minutes for the routine neuter on the 4-month-old feline.There were no difficulties when it was placed, and no leakage noted when it was being used during the case.When the tape was removed, (scissors were not used) only the hub of the catheter and a small approximately 1 mm catheter remained with the tape, which was intact on the cat's right front leg.The remaining catheter was missing, and could not determine the location with x-rays, however, the feline had no ill-effects from the issue, and was released to the owner.There was speculation the feline may gave chewed on the catheter but did not seem likely since the tape was still intact on his leg.A follow up as wellness check for the feline is being planned soon.

Manufacturer Narrative

A1: patient identifier: cat.A5: ethnicity: not provided for animal use.A6: race: not provided for animal use.E3: occupation: lead vet tech.The actual device was not returned for evaluation; therefore, the details of the actual condition of the actual sample were unable to be determined.Instead, a reference photo of the actual sample was provided by the customer.The proximal hub was observed to have blood.The point of the separation of the catheter tube was diagonally cut.The catheter condition of the actual sample cannot be confirmed through the photo.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.A total of thirty-one (31) 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 production process.Since the material of the catheter tube has not changed, the tensile strength simulation result from the previous catheter tube breakage complaints (b)(4) and (b)(4) was used as part of the investigation.We challenged the tensile strength of our catheter tube through the manual pulling tube and bending test using resistance breakage tester.The catheter tube elongated, and an evident dent was observed.However, no breakage or holes were noted on the catheter tube that could result in the complaint.This shows that the catheter tube has high tensile strength and does not break easily even when a strong force is applied.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.As stated on the complaint details, the involved device was inserted and in place on the patient without any reported issues until the time it was removed, which indicates that the device performed properly.It is also most likely that the damage occurred during, or just prior to the removal process.We have 2 stages of visual inspection.The first station covers the overall condition of the product.The second station covers the inspection of the catheter tip and needle tip condition and the distance between the catheter tip and needle heel.Thus, defects on the catheter tube such as scratch, hole, crack, or partial cut can be 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 ; 4103927218
• MDR Report Key: 18509585
• MDR Text Key: 333210938
• Report Number: 3003902955-2023-00075
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2024

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: SROX2225V
• Device Lot Number: 230127SF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/13/2024
• Supplement Dates Manufacturer Received: 01/13/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2023
• 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: Male