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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
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/22/2018
Event Type  malfunction  
Event Description
Information was received indicating that one day following insertion of a smiths medical jelco® protectiv® safety i. V. Catheter, it was noted to be leaking a clear liquid. Upon assessment, the catheter was noted to be broken off 1-2 millimeters from the hub. The rest of the catheter was not present on the patient's skin or the iv dressing. The following day an x-ray was performed noting the catheter in the left arm of the patient. Subsequently, surgical procedure was performed to remove the catheter. There were no reported adverse effects.
 
Manufacturer Narrative
One a smiths medical jelco® proplusw. Catheter along with an extension set was returned for analysis. The sample was visually inspected under microscopic examination finding that a redirected cannula penetrated the catheter wall during deployment; leaving a classic v shape wall. The penetration was noted at the 6 o'clock location with reference to wing position during deployment. The failure mode is reported to occur when the cannula is partially retracted and then advanced while threading the catheter in to the vein. Based on the evidence, the complaint is confirmed and the root cause is noted to be from user interface.
 
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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 n
minneapolis,, MN 55442
7633833310
MDR Report Key7543415
MDR Text Key109219539
Report Number3012307300-2018-01628
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/04/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/24/2018 Patient Sequence Number: 1
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