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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROTECT IV PLUS SAFETY IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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SMITHS MEDICAL ASD, INC. PROTECT IV PLUS SAFETY IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problems Break (1069); Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
Investigation could not be performed given that the actual complaint product sample was not provided by the complainant. Smiths medical truly values the input of our customers and is committed to resolving quality related issues without evaluating the actual sample, we can't assess or confirm whether a quality related issue has resulted in the user's reported difficulties. In order to ensure that our products meet functional requirements, the dimensions of the catheter components (eyelet, tubing, and hub) are tightly controlled. During the manufacturing process, our catheters are tested to assure that the tubing will not tear, break or otherwise fail. During the manufacture, critical parameters are 100% controlled during the different phases. Once the catheters are assembled from the tube, eyelet and hub, the catheters are inspected in-process 100% in order to demonstrate that the catheter tube is properly secured to the hub. To further ensure our products meet functional requirements, in-process testing is performed by certified operators using statistically valid sampling plans at defined intervals. If any non-conformances are found, the product is isolated, non-conformed and immediate corrective action is taken. As reported, the reported event could not be verified and/or confirmed with confidence, therefore, no correction, corrective, or preventive actions will be conducted by the manufacturing facility at this time. Complaint information will continue to be monitored. Smiths medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly. Device history records could not be reviewed given that a lot was not provided.
 
Event Description
It was reported that a fragment of the protect iv plus safety iv catheter was retained in the patient, and had to be surgically removed. It is unclear if this was a product or user issue.
 
Manufacturer Narrative
Additional information was received indicating that no catheter fragment was found during the surgical intervention to remove the foreign body. No additional adverse patient effects were reported.
 
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Brand NamePROTECT IV PLUS SAFETY IV CATHETER
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
CT 06489
Manufacturer Contact
dave halverson
1265 grey fox road
st. paul, MN 55112
7633833310
MDR Report Key7537108
MDR Text Key109017619
Report Number3012307300-2018-01631
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 Received05/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/23/2018 Patient Sequence Number: 1
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