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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEO MEDICAL INC. NEOMAGIC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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NEO MEDICAL INC. NEOMAGIC CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 1943-1608
Device Problems Fluid/Blood Leak (1250); Failure to Advance (2524); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
Event Type  malfunction  
Event Description
Situation: quality and safety concerns related to the neomagic extended dwell catheter (edc) 1. 9 fr. X 8cm with style. Couldn¿t advance the neomagic edc catheters beyond the 7 centimeter mark due to roughness and irregularity on the catheter. There was an additional incident with catheter leakage at the 8 cm mark. Health care provider pulled lot #1028 catheters and re-inspected them and found that approximately ½ had this same roughness at the 7-8 centimeter mark. Communication was sent to neo medical inc. Neomedical response: sales/clinical representative was able to talk to the quality assurance team earlier this afternoon about the epivs and the possibility of what might be happening. Company representative sent a photo of the deflashing process of our epiv catheters. This is part of the molding process. Is the roughness you are referring to depicted on the 'after deflashing' picture? if so, this is normal to our catheter assemblies. Our qa team would just like to know if this is the issue.
 
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Brand NameNEOMAGIC
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
NEO MEDICAL INC.
1375 greg st ste 108
sparks NV 89431
MDR Report Key13860670
MDR Text Key287702359
Report Number13860670
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1943-1608
Device Catalogue Number1943-1608
Device Lot Number1028
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/07/2022
Event Location Hospital
Date Report to Manufacturer03/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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