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 Skin Inflammation/ Irritation (4545)

Event Date 08/16/2022

Event Type  malfunction  

Event Description

The user facility reported the involved device plastic sheath stayed lodged in the dog.The event occurred post procedure.Additional information was received on 18 august 2022: the procedure for the dog was routine dental.There was no difficulty placing the catheter, and there was no leakage of fluids during the one (1) hour and fifteen (15) minutes it was in place.The catheter was removed with no issues noted, and the dog was released to the owner's care.The dog was brought back 24 hours later, with the sheath he stated was found in the site where it had been placed, outside the skin.The hub was not attached.The length of the catheter returned appeared to be the full length.The dog was being treated with antibiotics, due to the site being inflamed.The dog was doing well and good condition.The dental procedure was successful with no apparent issue at time of the patient released to the owner.Additional information (b)(6) 2022: there was no issues during removal.The catheter was found inside skin of dog.

Manufacturer Narrative

Date of birth: patient is a canine, weight: patient is a canine, ethnicity: patient is a canine, race: patient is a canine, implanted date: device was not implanted, explanted date: device was not explanted, occupation: practice manager/vet tech.The actual sample has not been returned yet.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 detached catheter tube from the hub.Moreover, samples passed the catheter tube and catheter hub fitting force test and have higher tensile strength against our specification of >7.845n.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 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.The lot history file showed no related nonconformity or any irregularity that could lead to the complaint.Before shipment, qc conducts an outgoing inspection to check the condition of the product.All samples passed.There is no evidence that there was a pre-existing defect with the device related to either the materials or the manufacturing process.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.

Manufacturer Narrative

This report is being submitted as follow-up no.1 to report that this reported event has been deemed not reportable based upon the investigation of the actual sample.Inspection of the returned sample upon receipt found that the reported device was confirmed not to be manufactured by terumo (philippines) corporation; therefore, deeming this complaint not reportable.

Manufacturer Narrative

This report is being submitted as follow up no.2 to correct date received by manufacturer.In the initial report the date is incorrect.

• 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: 15437470
• MDR Text Key: 306318836
• Report Number: 3003902955-2022-00034
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• 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
• Device Lot Number: 210406SB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• 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
• Treatment: IV FLUID ADMINISTRATION
• Patient Age: 13 YR
• Patient Sex: Male