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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Unspecified Infection (1930); Irritation (1941)
Event Date 10/03/2017
Event Type  Injury  
Manufacturer Narrative
No sample was returned for evaluation. A review of the sterilization records was performed and found that all parameters comply with the specified requirements. A review of the device history record was performed and did not show anomalies related to the reported issue. Based on the evidence, a root cause was unable to be confirmed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after use of a jelco® i. V. Catheter, the patient experienced irritations of the vein, veinitis, and edema on the arm. The patient was undergoing treatment for an e. Coli infection at the time of the event. To address the irritation, veinitis, and edema, the e. Coli antibiotics were stopped, and the medical team provided "local cares" in accordance to service protocol. No permanent injury was reported, and the incident was "closed".
 
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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 ITALIA S.R.L.
via della stazione, 2
04010 latina scalo
latina,
IT
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7080390
MDR Text Key112493418
Report Number3012307300-2017-02509
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/04/2017 Patient Sequence Number: 1
Treatment
ROCEPHINE
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