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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 306501
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/11/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Information was received that a smiths medical catheter was stuck in the patient's arm.Upon removal, was met with resistance and a defect of the product was described as " the tip of the catheter looks bad".The iv site was noted to bleed slightly more than normal.
 
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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 Key8219757
Report Number3012307300-2019-00053
Device Sequence Number16226854
Product Code FOZ
UDI-Device Identifier10351688071163
UDI-Public10351688071163
Combination Product (Y/N)N
Initial Reporter StateVA
Initial Reporter CountryUS
PMA/510(K) Number
K990236
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Catalogue Number306501
Device Lot Number3678229
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/05/2018
Initial Report FDA Received Date01/04/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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