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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURFLO INTRAVENOUS CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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TERUMO PHILIPPINES CORPORATION TERUMO SURFLO INTRAVENOUS CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Use of Device Problem (1670)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/05/2021
Event Type  malfunction  
Manufacturer Narrative
Age: (b)(6).Ethnicity - patient is a canine.Race - patient is a canine.Lot number: requested, not provided.Expiration date - unknown due to unknown lot number.Udi - not applicable.Operator of device - unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to unknown lot number.The root cause of the complaint is due to user error.As stated on the complaint details, the catheter was cut during a routine dental cleaning and remained inside the patient.There is no reported problem on the device.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.No lot history file was checked since the complaint lot number is unknown.Qc conducts a visual inspection to check product quality prior to 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 (b)(4)) corporation (manufacturer) registration no.(b)(4).
 
Event Description
The customer reported that their pet was recently the unfortunate victim of a careless mistake during a routine dental cleaning.Approximately.85 inches of a sur-vet surflo 20ga 1 1/4" catheter was cut remains inside their dog.They were told that the catheter did not break and that it was cut.The customer would like to find out if the catheter material is reactive or not.The information will be used to make further care recommendations.Radiography was done to locate the remaining piece of the catheter which was found in the caudal lobe of the lung.A ct scan appointment is set and will be done in a few days to see if the piece has moved and to see how the dog's body is reacting to it.(b)(6) is an otherwise healthy spayed female labrador retriever (american strain) of (b)(6) lbs.And is (b)(6) old.The customer of the dog has been told that a best-case scenario the dog's body walls off the catheter in a cyst and that they just need to perform periodic monitoring.Additional information was received on 6july2021: per the animal owner: the piece of iv catheter was found lodged in an artery in the dog's lung.It is in line with the blood flow (not kinked or twisted).The hope is that it just remains in the lung and that no scarring occurs so the blood can continue to flow through it.Surgery was not recommended as the risk of surgery is greater than the risk of leaving it inside.A follow up ct scan is scheduled for august to see how the body is reacting to it being there.At the moment the dog appears to be doing ok and will resume to her regular routine.Her stamina is not back to where it was before the incident.The dog breathes heavier earlier than before during training and walks.Occasionally (two to 3 times a week) the dog has an unexplained cough or a couple of extra rapid breaths.There have been no signs of labored breathing and or sucked in stomach while breathing.Ct scan results were received.The document stated the below information: history: (b)(6) is a (b)(6) year-old, spayed female labrador retriever that was presented to the (b)(6) hospital ((b)(6)) general surgery service on (b)(6) 2021, for further evaluation regarding an iv catheter cannula foreign body present presumably in the circulatory system.During removal of an iv catheter following a routine dental cleaning, the distal end of the iv catheter cannula was inadvertently transected and released into the right cephalic vein.A cutdown to the right cephalic vein was attempted to retrieve the foreign body but attempts were unsuccessful.Another catheter was placed in the left cephalic vein, and (b)(6) was transferred to a (b)(6) hospital where comparative forelimb radiographs and thoracic radiographs were performed.The iv catheter cannula was confirmed to be radiopaque based on the forelimb radiographs, but the missing cannula was not evident on the views of the right forelimb.Based on a consultation with antech, the iv catheter cannula appeared to be evident on the lateral thoracic radiograph in the caudodorsal lung field, but the laterality (right versus left) was unable to be determined without further imaging.(b)(6) does not appear to have any clinical signs from the foreign body at this time.Procedures: three-view radiographs of the thorax was done on (b)(6) 2021.A radiopaque tube-shaped linear foreign body was in the caudodorsal lungs.There are no pulmonary infiltrates associated with this foreign body.The remainder of the thorax is unremarkable.Computed tomography of the thorax (under general anesthesia was conducted.The linear hyperattenuating foreign body was within the terminal portion of the right caudal lobar artery with no evidence of secondary changes within the associated vessels or pulmonary parenchyma.Left adrenal nodule.Rule out a benign lesion (ex: adenoma, hyperplasia, or myelolipoma) vs.Less likely a malignant lesion.Ultrasound monitoring of the nodule could be performed periodically.(b)(6) is at an ideal body weight and may resume her normal diet.After one week to allow the incision on her right front leg to heal, (b)(6) may return to her normal exercise and activity.Continue to watch for signs of exercise intolerance, lethargy, increased respiratory rate and effort, and/or coughing.If you notice any of these signs, please seek veterinary care for further evaluation.A repeated computed tomography (ct) scan in 2-3 months to assess for migration of the iv catheter cannula or for evidence of secondary changes to the surrounding lung parenchyma.Depending on those results, additional follow up recommendations can be made at that time.It was recommended to assess (b)(6) lungs every 6-12 months with chest radiographs.If there is concern based on the x-rays, a ct scan could be performed at that time.It was also recommended to monitor (b)(6) left adrenal nodule every 4-6 months with abdominal ultrasound to be sure it is not increasing in size.It was confirmed that the iv catheter cannula is present at the very end of a pulmonary artery (blood vessel in the lung) in (b)(6) right caudal lung lobe.Given the hollow nature of the iv catheter cannula, it was anticipated that blood will simply continue to flow through the catheter or the blood vessel or may undergo fibrosis.The chances that it could begin migrating through the lung tissue or form an abscess are likely low; however, a potential complication.With time, (b)(6) body may begin to create a sterile granuloma, or scar-like tissue around the iv catheter cannula.We would not expect for a granuloma to cause any clinical signs, but if it occurs and becomes progressive, a proactive option is pursuing removal of the affected lung lobe via a right caudal lung lobectomy later.Currently, we recommend monitoring (b)(6) activity and breathing patterns, and pursuing periodic imaging if desired.She is clear to return to her normal activities after the incision on her right front leg has healed.The nodule identified in (b)(6) left adrenal gland is of unknown significance.Benign adrenal nodules are common in dogs; however, we also cannot rule out the presence of a neoplasm (cancer).Adrenal glands are the organs that make natural cortisol and other hormones for the body to use.It was recommended that they monitor (b)(6) left adrenal nodule every 4-6 months with abdominal ultrasound to assess for progression of the nodule.If the nodule is noted to be increasing in size, surgical removal of the adrenal gland and associated mass may be recommended.
 
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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 Key12142808
MDR Text Key267095487
Report Number3003902955-2021-00033
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberN/A
Device Catalogue NumberSROX2032V
Was Device Available for Evaluation? No
Date Manufacturer Received06/09/2021
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 Number1
Patient Age7 YR
Patient Weight29
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