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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU SURFLO IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC

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TERUMO CORPORATION - KOFU SURFLO IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number N/A
Device Problems Material Separation (1562); Migration (4003)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/16/2022
Event Type  malfunction  
Manufacturer Narrative
Age & date of birth - requested, not provided. Patient sex - requested, not provided. Weight - requested, not provided. Ethnicity - patient is an animal. Race - patient is an animal. Expiration date - december 2026. Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Establishment address: (b)(6). Health professional: requested, unknown. Initial reporter occupation: director of the farm animal clinic. Device manufacture date - 01/11/22 ~ 01/15/22. (b)(4). One catheter tube, one catheter hub and two different types of tubes were returned for our investigation. The catheter tube was confirmed to be detached from the catheter hub. The catheter hub was received connected to two different types of rubber tubes for extension. Utilizing five of our retention samples of the reported lot number, the bonding strength of the inner needle was measured. The results were all shown within our internal standard. The concerned product is produced by fully automated machine, from assemble and fitting of inner needle and catheter, through to individual packaging and case labeling. Sampling inspection is conducted every eight hours, where inner needle bonding strength is measured for predefined number of samples. The manufacture inspection records of the reported lot number were traced back and reviewed, wherein no machine trouble, which may have contributed to defective inner needle bonding strength, was noted. Moreover, our quality inspection records show no inner needle detachment or out-of-spec of inner needle bonding strength. We were not able to identify the specific root cause, since, as aforementioned, no anomalies which may have contributed to defective inner needle bonding strength were noted in our retention samples and our manufacture inspection records checking. Terumo medical corporation (tmc) (importer) registration no. (b)(4) is submitting this report on behalf of kofu factory of terumo corporation (manufacturer) registration no. (b)(4).
 
Event Description
The user facility reported that the inner needle detached. After the terumo surflo i. V. Catheter involved was placed, removal of the inner needle was attempted, however it was discovered the inner needle was missing. There was no patient injury/medical or surgical intervention required. No health hazard was reported.
 
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Brand NameSURFLO IV CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
TERUMO CORPORATION - KOFU
1727-1, tsuiji-arai
showa-cho
nakakoma-gun, yamanashi 409-3 853
JA 409-3853
Manufacturer (Section G)
TERUMO CORPORATION - KOFU
reg. no. 9681835
1727-1 tsuiji-arai
showa-cho, nakakoma-gun, yamanashi 409-3 853
JA 409-3853
Manufacturer Contact
stephanie handy
reg. no. 2243441
950 elkton blvid
elkton, MD 21921
9499890491
MDR Report Key14673911
MDR Text Key293835448
Report Number9681835-2022-00007
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K891087
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberSR-OT1464C
Device Lot Number220107J
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Yes
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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