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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)

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L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN) Back to Search Results
Model Number 384516
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 08/28/2021
Event Type  malfunction  
Manufacturer Narrative
The sample is expected to return for evaluation. A follow-up report will be submitted once the sample has been received and reviewed.
 
Event Description
Cracked picc - leaking noticed under the dressing where the glue was stuck to the catheter. 1. 2 fr picc l-cath (argon) cat# 095-384516 lot# 11351102 inserted on (b)(6) 2021 device was removed and a new one needed to be placed.
 
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Brand NameL-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)
Type of DeviceL-CATH PICC
MDR Report Key12537532
MDR Text Key280902483
Report Number0001625425-2021-01087
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 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384516
Device Catalogue Number384516
Device Lot Number11351102
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/08/2021
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 Initial

Patient Treatment Data
Date Received: 09/27/2021 Patient Sequence Number: 1
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