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

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.

• Brand Name: PROTECT IV PLUS SAFETY IV CATHETER
• Type of Device: CATHETER, 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 Key: 7537108
• MDR Text Key: 109017619
• Report Number: 3012307300-2018-01631
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• 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 Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention