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 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: dog.Date of birth: requested, not provided.Weight: requested, not provided.Ethnicity: patient is a canine.Race: patient is a canine.Implanted date: device was not implanted.Explanted date: device was not explanted.Operator of device - unknown.Health professional: unknown.Occupation: practice manager.Based on our initial investigation, the root cause of the problem could not be identified yet.The actual sample for return is not yet received as of this time hence we could not provide detailed information of its actual condition.Evaluation will be conducted once the actual sample is received.Verification of retention samples showed no related defects on the catheter tube that would lead to catheter tube breakage.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 on tensile strength of our catheter tube was conducted through manual pulling 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 breakage.Also, the lot history file was checked and no irregularity or nonconformity was noted that may result in the complaint.Qc conducts a visual inspection to check product quality prior to shipment.No nonconformity related to the complaint was noted.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo ((b)(4)) corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the iv catheter was placed and flushed.The pet got fluids from it.When they went to give medication, the fluid wasn't advancing.They noticed the catheter was broken.Exploratory surgery was done on the dogs arm unsuccessful.They were unable to locate the catheter.The dog is in stable condition.Additional information was received on 29april2021: placed the catheter to give the dog fluids prior to further treatment for kidney issues.There were no problems placing the catheter.Fluids were delivered successfully for approximal 1 hour.When they were ending fluids an iv was used to flush for further meds to prep for surgery.They found only the hub end present, and the distal end was not visible.They applied tunicate immediately, and an x-ray was taken.They could visualize the distal end within the vein, not far from the entry site.A cut down was done at the entry site, but the distal piece had migrated into the dog.They were not able to locate after additional x-rays.The dog was stable, and was mobile, and behaving normally.When the catheter break was discovered there was evidence of fluid leaking at bandage area, and there was blood leakage noted.However, they know the dog was receiving fluids successfully since the fluid pump did not alarm.Approximately 1/3 of the catheter is still retained in hub, and 2/3 went into dog.

Manufacturer Narrative

The actual device has been returned for evaluation.Based on the results of our simulation and investigation, there is no evidence that there was a pre-existing defect with the device related to either the materials or manufacturing process.Although a definitive cause could not be confirmed, examination determined that the condition of the returned sample is most consistent with inadvertent damage due to contact with a sharp object since a diagonal clean cut was observed on the proximal end of the catheter tube.This was also observed on a simulated sample prior removal, intentional cutting of the catheter tube was conducted during the removal of the surgical tape.As stated on the complaint details, there has been no problem encountered when the device was inserted into the patient and during the course of the procedure.Although it was also mentioned that there is leakage of fluid and blood that was observed on the bandage, the pump did not alarm indicating that the patient was successfully receiving the fluids.Further evaluation on tensile strength of our catheter tube was conducted through manual pulling 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 breakage.We have 2 stages of 100% 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.Also, the lot history file was checked and no irregularity or nonconformity was noted that may result in catheter tube breakage.(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 technopark; binan, laguna,, ; RP
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 11864477
• MDR Text Key: 260720640
• Report Number: 3003902955-2021-00017
• 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: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: SROX2225V
• Device Lot Number: 200925SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2020
• 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: 13 YR