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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. CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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SMITHS MEDICAL ASD; INC. JELCO® PROTECTIV® SAFETY I.V. CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 305606
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 07/16/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Information was received indicating that upon removing a smiths medical jelco® protectiv® safety i.V.Catheter from the patient's left arm, the catheter was observed to be not attached.Subsequently, the patient had the 3cm piece of catheter surgically removed.There were no further adverse effects.
 
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Brand Name
JELCO® PROTECTIV® SAFETY I.V. CATHETER
Common Device Name
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
MDR Report Key9076023
Report Number3012307300-2019-05008
Device Sequence Number2529036
Product Code FOZ
UDI-Device Identifier10351688071101
UDI-Public10351688071101
Combination Product (Y/N)N
Initial Reporter StateMI
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) 09/17/2019
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 Health Professional
Device Expiration Date04/23/2022
Device Catalogue Number305606
Device Lot Number3804643
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/20/2019
Initial Report FDA Received Date09/17/2019
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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