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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET
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THE METRIX COMPANY SECURE; 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET Back to Search Results
Model Number 66631
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that a floating particle was found in 1 unit of the secure 3000 ml dual chamber eva bag with 5 port manifold fill set, lot 66631-a6472.The particle was noted by the pharmacy during the packing process after filling the bag.There is no report of patient injury or death.The particle has been isolated from the bag and has been sent to an external lab for evaluation.The source of the particle is being actively investigated.Should additional relevant information become available, a follow-up report will be filed.
 
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Brand Name
SECURE
Type of Device
3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET
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 Key11381803
MDR Text Key243760712
Report Number1937141-2021-00001
Device Sequence Number1
Product Code KPE
UDI-Device Identifier20812496011514
UDI-Public20812496011514
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K960581
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number66631
Device Catalogue Number66631
Device Lot Number66631-A6472
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Date Manufacturer Received01/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2020
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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