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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 Problem Break (1069)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  malfunction  
Manufacturer Narrative
The sample is unavailable for evaluation. Without such evidence to review, the complaint cannot be confirmed. If additional information is received in the future, a follow-up report will be submitted.
 
Event Description
Argon medical device first picc s/l breaking while in a baby. The nurse controlled the bleeding and a physician removed the line. Staff did not keep the original defective picc line. Patient safety will file a report through medwatch.
 
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Brand NameFIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
Type of DeviceFIRST PICC
MDR Report Key12207297
MDR Text Key264953011
Report Number0001625425-2021-01041
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
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/21/2021 Patient Sequence Number: 1
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