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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 Blood Loss (2597)
Event Date 08/21/2019
Event Type  Injury  
Manufacturer Narrative
Ten unused samples were returned for investigation. Visual inspections of the devices found them to be in good physical condition, with no nonconformances. Based on sample evaluation, the complaint cannot be confirmed as a manufacturing nonconformance. In order to assure that our products meet functional requirements, the dimensions of the catheter components (eyelet, tubing, and hub) are tightly controlled. During the manufacturing process, smiths catheters are tested to assure that the tubing will not tear, break or otherwise fail. During the manufacture, critical parameters are 100 percent controlled during the different phases. Once the catheters are assembled, the tube, eyelet, and hub are inspected to demonstrate that the catheter tube is properly secured to the hub. The reported customer complaint has not been confirmed.
 
Event Description
Information was received that while a smiths medical catheter was in use, patient noticed blood pooling at iv site, and it was subsequently removed. However, it was reported that while attempting to do so, the cannula di not withdraw from the patient's vein. Alcohol was used to determine if cannula could be seen. Pressure was given to the arm and a tourniquet applied to site; nailbed capillary was monitored. Patient was taken to surgery for removal of detached cannula. It was also reported that no foreign body could be seen on ct or film. The surgery was unsuccessful however. No further adverse effects reported.
 
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Brand NameSMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS JELCO SAFETY PROTECTIV
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 ASD, INC.
201 west queen street
southington CT 06489
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, MN 55442
MDR Report Key9088756
MDR Text Key159391101
Report Number3012307300-2019-05018
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number306601
Device Lot Number3832371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/19/2019 Patient Sequence Number: 1
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