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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. JELCO® PROTECTIV® SAFETY I.V. CATHETERS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 306339
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/16/2018
Event Type  malfunction  
Event Description
Information was received indicating that this peripheral intravenous catheter would not penetrate the skin. It was noted that it was not possible to place the catheter in the patient and another catheter had to be used. No adverse patient effects were reported.
 
Manufacturer Narrative
Two used units of jelco® protectiv® safety i. V. Catheter from the same lot number as this device were returned for analysis. The units were analyzed under magnification. No defect was found. The needle was sharp and the bevel didn't show any anomaly. The wall thickness and the trim length measurement were in compliance with the internal specification. The design history record review didn't show any anomaly. The complaint database review didn't show other complaints for the referenced defect.
 
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Brand NameJELCO® PROTECTIV® SAFETY I.V. 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
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7429592
MDR Text Key105445652
Report Number3012307300-2018-01127
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
Type of Report Initial,Followup
Report Date 08/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/27/2020
Device Catalogue Number306339
Device Lot Number3538378
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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