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 05/02/2022

Event Type  malfunction  

Event Description

The user facility reported that after surgery (spay), the client pulled the involved survet iv catheter out of the vein.Only half of the catheter came out (half broke off inside vein).Additional information was received on 03 may 2022: the procedure was a routine spay for a terror mix.There was no trouble placing the catheter and was in place for about 1 1/2 hours, with no leakage noted during that time and fluids were being delivered during the duration of the procedure.At the conclusion of the surgical spay, when the tech was removing the catheter, she said "wait that is way too short".The veterinarian stepped in and palpated the site and was able to remove the catheter which had only migrated a short distance from the site.The veterinarian had to cut down a small incision to grab it with forceps and stitched the small cut down back up.Fluids were introduced for the routine spay procedure.The procedure outcome was successful.The canine patient was released to the owner, after surgical spay.

Manufacturer Narrative

Patient identifier: (b)(6).Age & date of birth: requested, not provided.Weight: requested, not provided.Ethnicity: patient is a animal.Race: patient is a animal.Udi - not applicable.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: office manager - vet assistant.The actual device has not been returned for evaluation.There is no evidence that there was a pre-existing defect with the device related to either the materials or the manufacturing process.The actual sample is not currently available for evaluation.We will further confirm this conclusion once we have evaluated the actual sample.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 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.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.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.For this reason, investigation conclusions code 11 has been reference.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).

Manufacturer Narrative

The actual device has been returned for evaluation.The received actual sample was sealed in a biohazard plastic bag wherein the hub is still connected to an infusion connector.The blackish-red foreign material which was confirmed a dried blood was observed on the broken catheter tube.Both point of the separation of the catheter tube has diagonal cuts.The proximal hub and the distal portion of the catheter tube were measured using a steel ruler.The catheter length (distal portion) approximately measures 20mm while the remaining tube on the hub measures 5mm.If the length will be added, this is still within our specification of 22 to 28mm catheter length for finished products.The catheter tube (distal portion), proximal hub, and catheter tip were viewed under 50x-100x magnification.It was observed that both points of the separation have a clean-diagonal cut.The tube was dented near the cut portion and there is also stretch on the cut portion which is more likely because of the applied force.There are no unusual abnormalities observed on the catheter tip.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.Results were all passed against our specification of >7.845n.We have received seventeen (17) complaints covering fy20 to june 7, 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.The received broken catheter tube was viewed under magnification and it was observed that both point of separation has a clean diagonal cut.The tube is also dent, stretch and with blackish-red blood.Most likely, the defect happened wherein the catheter tube was cut by a sharp object.A simulation was conducted on the retention sample through the insertion of an iv catheter into the dummy arm.When the catheter tube was intentionally cut while cutting the surgical tape, the simulated sample showed a similar appearance to the actual sample.Moreover, the exposed part of the catheter tube of the simulated sample was around 1mm when fully inserted into the vein hence leakage will be encountered if there is pre-existing hole or damage.As stated on the complaint details, there were no issues identified while the intravenous catheter was in place on the patient until the removal of the catheter tube which indicates that the device was in used good condition.Therefore, it is also most likely that the damage occurred during, or just prior to the removal process.The retention samples were confirmed visually wherein no related defects were found that might lead to the complaint.The samples passed the related functional tests.Also, the lot history file was checked, and no irregularity or nonconformity was noted that may result in either catheter tube breakage or detached catheter tube from the hub.There is no evidence that there was a pre-existing defect with the device related to either the materials or the manufacturing process.The received broken catheter tube was viewed under magnification and it was observed that both point of separation has a clean diagonal cut is most consistent with inadvertent damage due to contact with a sharp object.This was also observed on the simulated sample as shown on simulation 3 wherein prior removal, intentional cutting of the catheter tube was conducted while still inserted into the dummy arm during removal of surgical tape.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.

• 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, phl ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 14524309
• MDR Text Key: 299484611
• Report Number: 3003902955-2022-00014
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

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: 210811SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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: FLUIDS
• Patient Sex: Female