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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. JELCO PROTECTIV SAFETY IV CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Model Number 307300
Device Problems Material Frayed (1262); Material Perforation (2205); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
Event Type  malfunction  
Event Description
It was reported that the catheter tips were fraying upon insertion. The needle was poking through catheter tip. The needle tip was bent prior to packages being opened and the catheter was flimsy enough to be bent with air blowing on it, causing multiple sticks upon insertion. No patient injury was reported.
 
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Brand NameJELCO PROTECTIV SAFETY IV CATHETERS
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14146800
MDR Text Key289609271
Report Number3012307300-2022-06649
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number307300
Device Catalogue Number307300
Device Lot Number4169776
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1218-2019, Z-0789-2017

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