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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. JELCO CONVENTIONAL JELCO IV CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 4032-AI4
Device Problems Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 04/05/2018
Event Type  malfunction  
Event Description
It was reported that during the intervention of the venous access to the patient, the device retracted and generated discomfort and injury. Due to this, it was necessary to change the venous access on two occasions. There were no reported adverse effects.
 
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Brand NameJELCO CONVENTIONAL JELCO IV 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 INTERNATIONAL LTD
1500, eureka park
lower pemberton
ashford, kent TN25 4BF
UK TN25 4BF
Manufacturer Contact
dave halverson
1265 grey fox road
st. paul, MN 55112
7633833310
MDR Report Key7759219
MDR Text Key116311486
Report Number3012307300-2018-03236
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 08/07/2018
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 Date08/04/2022
Device Catalogue Number4032-AI4
Device Lot Number3466799
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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