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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN

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FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN Back to Search Results
Model Number 384221
Device Problems Material Fragmentation (1261); Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 06/08/2021
Event Type  malfunction  
Manufacturer Narrative
No sample or images are available for evaluation. Without such evidence to review, the complaint cannot be confirmed. If additional information is provided in the future, a follow-up report will be submitted.
Event Description
Central catheter was inserted in a newborn on (b)(6) 2021, during the course of the same day the device was replaced. At the occasion there was rupture of the device, with displacement of an 8cm fragment to the cardiac area. The removal of the fragment occurred on (b)(6) 2021 by the vascular surgery team. Soon after the procedure, the patient had a clinical worsening of the condition, evolving with tonic-clonic movements. Adverse event: tonic clonic seizures. ".
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Brand NameFIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
Type of DeviceFIRST PICC
MDR Report Key12425509
MDR Text Key271263710
Report Number0001625425-2021-01075
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model Number384221
Device Catalogue Number384221
Device Lot Number11275539
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/18/2021
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: 09/03/2021 Patient Sequence Number: 1