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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
Lot Number UNKNOWN
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 01/10/2020
Event Type  Injury  
Event Description
Information was received indicating that upon the removal of a smiths medical peripheral intravenous catheters (pivc)|jelco safety protectiv catheter, the catheter came off the hub and got stuck in the patient. Subsequently, patient was taken to procedural area where venotomy was performed removing the retained catheter lumen, noted to be otherwise intact. No further effects were reported.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
MDR Report Key12469975
MDR Text Key271353770
Report Number3012307300-2021-09355
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 company representative
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberUNKNOWN
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
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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