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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION SET 60DROP STAT2 SPLIT SEP SET, ADMINISTRATION, INTRAVASCULAR

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CONMED CORPORATION SET 60DROP STAT2 SPLIT SEP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number S2V-60
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The user facility, (b)(6) hospital, reported the device was not allowing fluid/drugs to drip properly. The device was returned, flow rate was tested during evaluation and the complaint was not confirmed. The device was able to regulate flow consistently, turn off and run full open properly. Variation in drip rate is expected with this product. The instruction for use cautions the user that dial numbers are approximate. Medical professionals should confirm drip rate by using timer or watch with a second hand. The product specification states there must be a continuous increase in flow rate when the dial is turned from off to full. This device met specification. The complaint product was re-evaluated as part of a root cause investigation on 08 jun 2017. Engineers disassembled the item to evaluate the internal drum. The drum channel was incorrect and is being addressed with a supplier corrective action request. Based on these findings, this complaint is considered confirmed and supplier related.
 
Event Description
The user facility reported the device was not allowing fluids/drugs to drip properly. No additional information was provided.
 
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Brand NameSET 60DROP STAT2 SPLIT SEP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CONMED CORPORATION
525 french road
utica NY 13502 5994
Manufacturer (Section G)
CONMED CORPORATION
525 french road
utica NY 13502 5994
Manufacturer Contact
lindsey sheppard
525 french road
utica, NY 13502-5994
MDR Report Key6636866
MDR Text Key77616861
Report Number3007305485-2017-00137
Device Sequence Number1
Product Code LDR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K905498A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 06/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/12/2020
Device Catalogue NumberS2V-60
Device Lot Number201507144
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2015
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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