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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

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FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM Back to Search Results
Model Number 384232
Device Problems Detachment of Device or Device Component (2907); Gas Leak (2946)
Patient Problem Insufficient Information (4580)
Event Date 06/10/2021
Event Type  malfunction  
Manufacturer Narrative
Sample was returned for evaluation. A follow-up report will be submitted once the investigation has been completed.
 
Event Description
Picc popped and bubbled fluids at point in between oval disc and silicone catheter beginning. No patient harm but occurred during a flush of the catheter and in-dwelling. Picc removed and replaced with peripheral iv.
 
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Brand NameFIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
Type of DeviceFIRST PICC
MDR Report Key12136140
MDR Text Key262888744
Report Number0001625425-2021-01015
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K972262
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384232
Device Catalogue Number384232
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/08/2021 Patient Sequence Number: 1
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