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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

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SMITHS MEDICAL ASD, INC. JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Model Number 326710
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 01/04/2020
Event Type  malfunction  
Event Description
Information was received indicating that at the end of therapy with a smiths medical peripheral intravenous catheters (pivc)|jelco safety viavalve catheter, it was noted that the catheter was not attached to the hub. It was also reported that the tip of the catheter was never found, and the patient was discharged in a stable condition. No further adverse effects were reported.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
MDR Report Key12474183
MDR Text Key271466807
Report Number3012307300-2021-09364
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K160235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
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 Model Number326710
Device Catalogue Number326710
Device Lot Number3850520
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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