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
(b)(4).This device is same and/or similar to a device approved for distribution in the us.
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
The complainant returned two "5 up strips" that were missing the 14ga "orange color bar" for evaluation.Upon reviewing the two strips, they were confirmed to be cavity #'s 1-5 and 6-0, which 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.Device history record was reviewed.The product was packaged on ffs #11 on the 22nd of april 2017.No discrepancies or abnormalities relevant to the complaint.

• 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: 7389942
• Report Number: 3012307300-2018-00899
• Device Sequence Number: 1417565
• 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): 05/30/2018

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: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1