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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® I.V. CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL ASD, INC. JELCO® I.V. CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 4033-AI
Device Problems Disconnection (1171); Difficult to Insert (1316); Difficult to Remove (1528)
Patient Problem Distress (2329)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the white plastic tube disconnects from the needle and yellow connector part. Due to this issue, there were problems when inserting the needle, causing the vein to be damaged and being unable to keep the iv catheter in and difficult to remove. Due to the incident, the patient was under distress and the catheter had to be removed. No other injury reported.
 
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Brand NameJELCO® I.V. CATHETER
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 TN25 4BF
UK TN25 4BF
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7292619
MDR Text Key100809483
Report Number3012307300-2018-00347
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 02/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4033-AI
Device Lot Number3533650
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2017
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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