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U.S. Department of Health and Human Services

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

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POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 8672034
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of asesf900 showed five similar product complaint(s) from this lot number.
 
Event Description
It was reported that cap on y connection dislodged about an hour after infusion started, causing medication to be lost. Medication was being infused via main port. Per healthcare professional " the cap wasn't checked no - but this will definitely be something we do from now on. We did not feel the cap was faulty, but as we didn't check, we are unsure. " no other information was provided.
 
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Brand NamePOWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12167734
MDR Text Key261524503
Report Number3006260740-2021-02748
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K060812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8672034
Device Catalogue Number8672034
Device Lot NumberASESF900
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2020
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: 07/14/2021 Patient Sequence Number: 1
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