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
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is same and/or similar to a device approved for distribution in the u.S.
Event or Problem Description
It was reported that the packaging of a jelco® viavalve® safety iv catheter was white with no orange strip.No injury was reported.
Additional 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
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7389935
• Report Number: 3012307300-2018-00905
• Device Sequence Number: 18881113
• Product Code: FOZ
• UDI-Device Identifier: 10351688077851
• UDI-Public: 10351688077851
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1