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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR

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MINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of asfsf203 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that "(miniloc) leaked after tightening. They are currently using a medlin kit with two positive pressure needles valves, they are in process of putting t. " additional information rcvd 09/27/2021: "i do not have specific lot numbers for these incidents, but the leakage has happened with almost every needle (and continues to) since we started using the product approximately one month ago. The cap on the lower port is loose which allows the blood to leak out. We use approximately 30-50 port needles per day. ".
 
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Brand NameMINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12627894
MDR Text Key276388666
Report Number3006260740-2021-04353
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K050600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0682034
Device Lot NumberASFSF203
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/13/2021 Patient Sequence Number: 1
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