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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, SHORT-TERM LESS THAN 30 DAYS

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TERUMO CORPORATION - KOFU SURFLO IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number SR-OT2232C
Device Problem Break (1069)
Patient Problem No Code Available (3191)
Event Date 04/07/2020
Event Type  Injury  
Manufacturer Narrative
Patient identifier - requested, not provided. Age & date of birth - requested, not provided. Sex - requested, not provided. Weight - requested, not provided. Ethnicity - requested, not provided. Race - requested, not provided. Lot number - requested, not provided. Expiration date - unknown due to unknown lot number. Udi - udi number is not required for this product code. Implanted date - device was not implanted. Explanted date - device was not explanted. Device manufacture date - unknown due to unknown lot number. The actual device was returned for evaluation. Visual inspection revealed a scratch approximately 4. 5mm away from the catheter tip. When the damaged portion was closely observed under a microscope, the scratch was v-shape damage, in which the inner-needle had created while it was being punctured through the catheter, was observed. Ifu states: "do not attempt to re-insert a partially or completely withdrawn needle. " the production lot number was not provided by the user facility. The manufacture inspection records for the past five years were traced and reviewed, and no irregularity was observed. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. Based on the investigation results it is likely that re-insertion of the needle, which resulted in creating a v-shape scratch and it blocked to being removed may have caused the reported event. However, the exact cause of the reported event cannot be definitively determined based on the available information. Terumo medical products (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 surflo iv catheter was damaged. On (b)(6) 2020, the nurse tried to place the catheter on a bedridden patient. However, as he/she could not confirm a flush he/she tried to remove the catheter but felt that catheter being caught, and he/she could not remove it. An attending doctor made an incision using an 18g needle and removed the catheter. After removal, it was determined none remained in the body since it was measured to be the same length as an unused sample. The treatment was finished by the incision. The catheter was removed successfully. On (b)(6) 2020, the information was received from (b)(6) center via distributor, (b)(4). On (b)(6) 2020, during the interview with mr. /ms. (b)(6), who is the medical safety chief officer, he/she mentioned this has probably occurred due to mishandling procedure of catheter placement. However, he/she decided to ask the investigation to the manufacturer as a result of discussion with a director of nursing department.
 
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Brand NameSURFLO IV CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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 409-3 853
JA 409-3853
Manufacturer Contact
theresa mussaw
950 elkton blvd
elkton, md 
2837866718
MDR Report Key10017356
MDR Text Key194400649
Report Number9681835-2020-00002
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSR-OT2232C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2020
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

Patient Treatment Data
Date Received: 05/01/2020 Patient Sequence Number: 1
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