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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

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JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Catalog Number 4030-AB
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 10/04/2019
Event Type  malfunction  
Event Description
Information was received indicating a smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter was noted to be bent in the act of puncture causing it to break. No adverse effects were reported.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
MDR Report Key12474969
MDR Text Key271492603
Report Number3012307300-2021-09371
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial
Report Date 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4030-AB
Device Lot Number3638013
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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