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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 306001
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/31/2018
Event Type  Injury  
Event Description
Information was received indicating that a smiths medical jelco® protectiv® safety i. V. Catheter was found to be leaking around the hub. The iv was then removed and the catheter tip was noted to be separated from the hub. An x-ray, cat-scan and echocardiogram were performed to locate the catheter. Subsequently, exploratory surgery was necessary to attempt to find the retained catheter. There were no further reported adverse effects.
 
Manufacturer Narrative
Evaluation summary: a device was not returned for investigation. However, two photographs, one of a detached/severed catheter just above the catheter hub nose, with no photo of the unattached segment, and the other a reference photo of a non-defective catheter sample were returned to the manufacturer. The photograph of the defective sample did not include a magnified close up view of the detachment point. Additionally, a device history record review was completed and no manufacturing issues were found. With no device returned, an in depth evaluation could not be performed and no specific root cause can be identified. Based on the photographs and device history review, the complaint allegation was confirmed with no noted problem source.
 
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Brand NameJELCO® PROTECTIV® SAFETY I.V. CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
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 Key7828110
MDR Text Key118607459
Report Number3012307300-2018-03499
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/12/2020
Device Catalogue Number306001
Device Lot Number3423775
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2017
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: 08/29/2018 Patient Sequence Number: 1
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