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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

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L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM Back to Search Results
Model Number 384539
Device Problem Device Slipped (1584)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
The device was returned, but has not been evaluated yet. A follow-up report will be submitted after the device has been evaluated.
 
Event Description
Rn went to flush the y-piece and the yellow/amber piece that holds the stylet popped out.
 
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Brand NameL-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
Type of DeviceL-CATH PICC
MDR Report Key12611757
MDR Text Key277728443
Report Number0001625425-2021-01094
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384539
Device Lot Number11277484
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/16/2021
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: 10/11/2021 Patient Sequence Number: 1
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