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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 Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 01/01/1901
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical peripheral intravenous catheters (pivc)|jelco safety viavalve catheter, broke while it was being inserted by the nurse. It was also reported that the broken piece of needle stayed in the actual catheter. No 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 Key12474364
MDR Text Key271471556
Report Number3012307300-2021-09365
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 company representative
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 Expiration Date09/16/2021
Device Model Number326710
Device Catalogue Number326710
Device Lot Number3868797
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 Manufactured09/30/2019
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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