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

Catalog Number SR-FVP2032P

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the customer attempted to puncture a jelco® viavalve® safety iv catheter to a patient, but could not at all.They then used another one and were able to do it with no problem.No patient injury.

Manufacturer Narrative

One used catheter was received for investigation.Examination of the returned sample via microscopy determined a burr\hook was present on the cannulae point.The as returned images do show the condition.The sample needed to be cleaned to remove all of the blood and residue from the cannulae point for further examination.When attempting to clean the point additional damage was done to the cannulae point by this examiner rolling the edge of the left lancet and making the burr\hook condition worse.As a result the examination was terminated.Based on the as returned examination that revealed a hook\burr condition existed it is reasonable to conclude a manufacturing defect is confirmed.It is inconclusive at to the origin of the hook\burr.

• Brand Name: JELCO® VIAVALVE® 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; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7400394
• MDR Text Key: 104522594
• Report Number: 3012307300-2018-00808
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2020
• Device Catalogue Number: SR-FVP2032P
• Device Lot Number: 3521444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1