Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN Back to Search Results
Model Number 384221
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/08/2021
Type of Reportable Event Malfunction
Additional 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 or Problem 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.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FIRST PICC S/L 26GA (1.9F) X 50CM 1 LUMEN
Common Device Name
FIRST PICC
MDR Report Key12425509
Report Number0001625425-2021-01075
Device Sequence Number19761473
Product Code FOZ
UDI-Device Identifier00886333209743
UDI-Public00886333209743
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K972262
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
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
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/18/2021
Initial Report FDA Received Date09/03/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device N
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-