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 Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/25/2022

Event Type  Injury  

Event Description

Terumo medical received an fda medwatch report # mw5109510.The event description stated that during the removal of iv, the catheter portion fractured.An ultrasound was performed.The findings consistent with the retained catheter in the right basilic vein.The patient required invasive procedure for removal.Additional information was received 16 jun 2022: there was no procedure performed for the patient prior to the catheter being removed.The iv had been placed approximately 6 days prior to removal.It was unknown if there was difficulty placing the catheter in the patient's vein.There was no leakage noted during the time of placement and it was not noted if there was leakage on the cover bandage at time of removal.The iv had already been fractured when the bandage was removed.It was not noted if the catheter became fractured during removal.Surgical intervention was located, and the fractured catheter fragment was successfully removed from the patient.The patient condition was stable at the time of the event.The catheter fragment located in the basilic vein was about 1.8 inches.The facility is not new to using this specific product.

Manufacturer Narrative

This report is being submitted as an initial report for mdr 3003902955-2022-00017 which was submitted on june 24th of 2022 however was missing the 3rd acknowledgment.The initial mdr was attempted to be submitted a few times to try and receive the third missing acknowledgment.Email correspondence between esg and cesub help desk have been attached as they were unable to provide a third acknowledgement for any of the attempted submissions.As per their request to resubmit, a follow up report was submitted however failed.To void anymore issues with mfr number 3003902955-2022-00017 a new mfr number was created to ensure the initial information was submitted.Patient identifier: requested, not releasable.Age & date of birth: requested, not releasable.Patient sex: requested, not releasable.Weight: requested, not releasable.Ethnicity: requested, not releasable.Race: requested, not releasable.Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Udi: unknown - not releasable.Implanted date: device was not implanted.Explanted date: device was not explanted.Health professional: requested, unknown.Device manufacture date: unknown due to unknown lot number.The actual sample was not available for evaluation hence we cannot provide detailed information on its actual condition.Since the lot number is unknown, a retention sample evaluation was not performed.Seventeen (17) complaints covering fy20 to (b)(6) 2022, related to this issue where the cause was not identified related to our product and production process.Since the material of the catheter tube has not changed, the tensile strength simulation result from the previous catheter tube breakage complaints was used as part of the investigation.There is no evidence that there was a pre-existing defect with the device related to either the materials or the manufacturing process.As stated in the complaint details, the iv catheter was broken during removal which indicates that the device was used without any problem.The probability of the breakage cannot be confirmed due to limited information that was provided and the actual sample was not available for evaluation.Most likely, the catheter tube was accidentally cut during the removal of the surgical tape where the catheter tube adhered.Further evaluation of the tensile strength of our catheter tube was conducted through manual pulling and bending test 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.No lot history file was checked since the complaint lot number is unknown.Qc conducts a visual inspection to check product quality before shipment.Only passed samples are allowed to be shipped.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; biñan ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan ; RP
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 15069851
• MDR Text Key: 296290289
• Report Number: 3003902955-2022-00028
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SR-OX2051CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2022
• Initial Date FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other