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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 50ML 2 PORT EVA BAG
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THE METRIX COMPANY SECURE; 50ML 2 PORT EVA BAG Back to Search Results
Model Number 66043
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that particulate was found in 11 units of the secure 50 ml 2 port eva bags, lot 66043-a6389.The particulate was noted by the same pharmacy upon the inspection of the bags at the time of filling or after the bags were filled.There is no report of patient injury or death.The particulates were isolated by a third party lab and analyzed via ftir.The results of the ftir indicate the particulates are most likely rayon, polyester and eva.The source of these particulates is actively being investigated.Should additional relevant information become available, a follow-up report will be filed.
 
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Brand Name
SECURE
Type of Device
50ML 2 PORT EVA BAG
Manufacturer (Section D)
THE METRIX COMPANY
4400 chavenelle road
dubuque IA 52002
Manufacturer (Section G)
METRIX DOMINICANA
parque industrial itabo
building 5
san cristobal,
DR  
Manufacturer Contact
jennifer clasen
4400 chavenelle road
dubuque, IA 52002
5635568800
MDR Report Key10874715
MDR Text Key221287336
Report Number1937141-2020-00003
Device Sequence Number1
Product Code KPE
UDI-Device Identifier50812496011577
UDI-Public50812496011577
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030888
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/24/2023
Device Model Number66043
Device Catalogue Number66043
Device Lot Number66043-A6389
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Date Manufacturer Received08/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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