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

Catalog Number 326800

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that the packaging of a jelco® viavalve® safety iv catheter was white with no orange strip.No injury was reported.

Manufacturer Narrative

Customer returned 2 (5 up strips) of jelco® viavalve® safety iv catheters missing the 14ga "orange color bar" for evaluation.Upon review of the two strips, they were confirmed to be (cavity #'s 1-5 and 6-0) represented one full machine cycle.In the packaging operation, 10 blister packages are produced simultaneously.The investigation did confirm that the product failed to meet the expected performance as a result of a manufacturing related issue.

• 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 NORTH AMERICA; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7389919
• MDR Text Key: 104263025
• Report Number: 3012307300-2018-00904
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688077851
• UDI-Public: 10351688077851
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2019
• Device Catalogue Number: 326800
• Device Lot Number: 3417549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• 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