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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 Problems Break (1069); Stretched (1601); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2019
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation - surgery tech. The actual device has been returned for evaluation. Based on the results of our investigation, the exact root cause of the complaint could not be identified. The actual sample received showed an iv catheter cut into two pieces wherein the tip of the catheter tube that remained on catheter hub was observed elongated and appears to be unevenly cut twisted portion on the tube was noted. However, as informed through the complaint details, it was noted that the iv was not flushing appropriately, and that no leakage occurred. Most likely, the breakage of the catheter tube occurred during usage specifically during replacement since leakage was not observed prior breakage was reported. Moreover, verification on received same lot sample and retention sample showed no defects found such as crack, pinhole, and scratch, bent and broken parts on catheter tube that would lead to catheter tube breakage. No damaged or deformed catheter tube that might lead to the complaint. Received same lot sample and retention samples were also evaluated for catheter tube and catheter hub fitting force. All samples passed. We have 2 stages of 100% visual inspection. The first station covers the overall condition of the product. The second station covers inspection of catheter tip and needle tip condition and the distance between catheter tip and needle heel. Thus, defects on catheter tube such as scratch, hole, crack or partial cut can be detected during these processes. In addition, lot history file showed that no non-conformities or troubles related to the complaint was encountered. Furthermore, qc conducts visual inspection to check product quality prior shipment. No nonconformity related to the complaint was noted. (b)(4).
 
Event Description
The user facility reported that they went to remove the catheter and it came apart. A part remained in the patient and had to be removed with forceps. Additional information received on march 7, 2019: the catheter was placed for neuter of pomeranian, less than year old. It was reported that it was only placed for a short time (approx. Five minutes), and was not flushing appropriately, but no leakage had occurred. When they tried to replace the catheter, it was noted it had separated in two pieces, they were able to retrieve it with forceps from the animal. They were able to replace the catheter and continue to successful neuter the canine without further incident. There was no harm to the dog. The facility has proximal and distal portions of catheter for investigation pack is being sent. The facility requests response letter for their file.
 
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Brand NameTERUMO SURFLO INTRAVENOUS CATHETER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TERUMO PHILIPPINES CORPORATION
124 east main avenue
laguna technopark
binan, laguna
RP
Manufacturer (Section G)
TERUMO PHILIPPINES CORPORATION
124 east main avenue
laguna technopark
binan, laguna,, reg. no. 3003902955
RP
Manufacturer Contact
theresa mussaw
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key8469692
MDR Text Key140614667
Report Number3003902955-2019-00016
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberSROX2419V
Device Lot Number180414SB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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