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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY PROTECTIV CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL ASD, INC. JELCO SAFETY PROTECTIV CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 307300
Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that over the last several months the facility staff were reporting multiple problems with the jelco safety protect iv catheter. The catheter was not exhibiting a flash back of blood, including those that were performed with the assistance of a venous illuminator, where venous access could be validated. The problem has created multiple iv access attempts on a very vulnerable neonatal patient population, and even those infants that are full term with easily accessible access.
 
Manufacturer Narrative
One jelco safety protect iv catheter was returned for analysis. The introducer was noted to be delivered with the guard fully advanced (locked out), the catheter assembly was loose, the catheter assembly tube was flattened in front of the hub component and no unusual conditions present within the introducer. The catheter tube was noted to have light and dark areas that indicate the presence of material inside the catheter tube. The flattening of the tube may be due to routine handling (the sample being loose in the delivery packaging). Testing of the catheter using a water filled syringe indicated that it is not obstructed as water flowed through it. Testing of fluid flow through the introducer per smiths standard test method confirmed that flashback (fluid flow) did not occur. A wire probe inserted into the cannula lumen stopped at approximately. 25 inches travel, indicating a blockage. The resistance to advancement was greater than the bending strength of the wire. Previous experience with used introducers shows that dried blood does not offer the resistance encountered; it is inferred that the blockage is due to something else. Based on the findings above, the complaint is confirmed but the root cause is unknown. Since actual type of blockage could not be determined by investigator, and since there was no other similar complaints reported for this lot, this event is considered to be an isolated event and not the result of a systemic quality related issue.
 
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Brand NameJELCO SAFETY PROTECTIV CATHETERS
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL NORTH AMERICA
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
1265 grey fox road
st. paul, MN 55112
7633833310
MDR Report Key7759266
MDR Text Key116374467
Report Number3012307300-2018-03239
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 other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/19/2020
Device Catalogue Number307300
Device Lot Number3491237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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