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U.S. Department of Health and Human Services

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

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TERUMO SURFLO INTRAVENOUS CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Udi - not applicable. Operator of device - unknown. Implanted date: device was not implanted. Explanted date: device was not explanted. The root cause of the complaint could not be identified. We cannot confirm the condition of the actual sample since it was not returned by the customer for our evaluation. Moreover, checking of lot history files and the retention samples showed that no related non-conformities may contribute to the complaint. Our cannula is a supplied raw material that complies with iso 9626, particularly on stiffness and breakage. This was further confirmed when the retention sample did not break after bending it forty times. We have series of visual inspections to check the condition of the product that might lead to the complaint. We also 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. Also, the lot history file was checked and no irregularity or nonconformity was noted that may result in catheter tube breakage. Before shipment, qc also conducts an outgoing inspection to check product quality before shipment. No nonconformity related to the complaint was noted. (b)(4).
 
Event Description
The clinic reported that a piece of the metal stylet broke off when removing the catheter of survet 20g x 1 (srox2025v).
 
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Brand NameTERUMO SURFLO INTRAVENOUS CATHETER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12712895
MDR Text Key279890203
Report Number3003902955-2021-00053
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K133280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberSROX2025V
Device Lot Number210127SD
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/27/2021
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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