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 01/24/2024

Event Type  malfunction  

Event Description

The user facility reported that the end of a sur-vet surflo iv catheter was lost during a dental procedure.The reported event resulted in patient injury and/or require medical or surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.A radiographs was performed on (b)(6) 2024.On (b)(6) 2024, the havanese dog was admitted for a dental procedure.A 24g x3/4 catheter was placed in the right cephalic vein with no unusual issues.The catheter was well taped in place and dog was anesthetized and the required dental work was completed.Approximately 6 hours after being placed the catheter was removed.When it was pulled from the vein it was obviously shortened by approximately 1 cm.Nothing palpated along the cephalic vein.No abnormal behavior had been noted prior to catheter removal.The taping around the catheter was searched as was the surrounding room for the other piece of catheter with no success.The doctor had placed the remaining catheter alongside a new one and there was approximately 1 cm of the end missing.The dog continued to show no clinical signs of distress.She called a veterinary cardiologist for some further information.They had only heard of this happening once before, years ago and unsure of the outcome.As the dog was doing well, arrangement was made to send the dog home after a long discussion about the catheter.The next day the dog came back for radiographs of the chest and left front leg - looking for any sign of the catheter.None were found.The dog is being monitored and he is doing well at home.The doctor is working on the assumption that the catheter end is still in the dog.Additional information was received on 05 mar 2024: there was no blood loss experienced.

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: date of birth: 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.D4: potential lot #: 1) 220615sc & 2) 220811sb.D4: potential expiration date: 1) 31-may-2027 and 2) 31-jul-2027.D4: udi: not applicable d6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: potential device manufacture date: 1) 15 jun 2022 & 2) 11 aug 2022.The actual sample is not available for evaluation therefore the details of the actual condition of the sample in unable to 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 (b)(4)).Results were all passed against our specification of >5.884n.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 thirty-four (34) 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.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 lots.There were no reported issues with the product when it was inserted into the vein or during the 6-hour period it was used, indicating that the device worked properly.The damage likely occurred during the removal process.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.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: 18966155
• MDR Text Key: 338617308
• Report Number: 3003902955-2024-00014
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/AK133280
• 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
• Report Date: 03/22/2024

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: SROX2419V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/23/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 14 YR
• Patient Sex: Male