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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS JELCO SAFETY PROTECTIV; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS JELCO SAFETY PROTECTIV; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 306601
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2019
Event Type  Injury  
Event Description
Information was received that upon removal of a smiths medical catheter, device had fragmented.An xray was conducted of the patient, confirming the catheter piece was in the left arm.Patient was transferred to children's hospital (b)(6) to remove the remaining catheter.No patient injury resulted.
 
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Brand Name
SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS JELCO SAFETY PROTECTIV
Type of Device
CATHETER, 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 ASD, INC.
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, MN 55442
MDR Report Key9204672
MDR Text Key162720181
Report Number3012307300-2019-05754
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier10351688071224
UDI-Public10351688071224
Combination Product (y/n)N
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Catalogue Number306601
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/20/2019
Initial Date FDA Received10/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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