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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 306601
Medical Device Problem Code Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/26/2018
Type of Reportable Event Malfunction
Event or Problem Description
Information was received that a smiths medical catheter was leaking.The cannula had broken off and remained in patient's hand.
 
Event or Problem Description
This report is a correction.Initial was submitted in error.No intervention was required for cannula piece that remained in the patient's hand upon removal.
 
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Brand Name
JELCO® PROTECTIV® SAFETY I.V. CATHETERS
Common Device Name
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8191541
Report Number3012307300-2018-08978
Device Sequence Number19323008
Product Code FOZ
UDI-Device Identifier10351688071170
UDI-Public10351688071170
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K990236
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Catalogue Number306601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2018
Supplement Date Received by Manufacturer11/26/2018
Initial Report FDA Received Date12/21/2018
Supplement Report FDA Received Date02/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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