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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FIRST PICC S/L 18GA (4F) 1.35MM X 65CM
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FIRST PICC S/L 18GA (4F) 1.35MM X 65CM Back to Search Results
Model Number 384157
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/03/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The sample is unavailable 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
"catheter introduced on (b)(6) 2020 without intercurrence.(b)(6) 2020 it was identified in the sterile dressing a small hole in the catheter near the oval disc.".
 
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Brand Name
FIRST PICC S/L 18GA (4F) 1.35MM X 65CM
Common Device Name
FIRST PICC
MDR Report Key12310263
Report Number0001625425-2021-01058
Device Sequence Number11755710
Product Code FOZ
UDI-Device Identifier00886333209682
UDI-Public00886333209682
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 user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/11/2021
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 Date06/30/2023
Device Model Number384157
Device Catalogue Number384157
Device Lot Number11317182
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 06/28/2021
Initial Report FDA Received Date08/11/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured06/30/2020
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;
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