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

Catalog Number	326310
Medical Device Problem Codes	Dull, Blunt (2407); Difficult to Advance (2920)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that clinicians in the field have noted that this needle appeared to be dull.The nurses found difficulty piercing the skin with the needle.It was also noted that the patient felt discomfort and that the needle would not advance into the vein.Pressure was applied to the site to stop any bleeding after piercing the skin.No adverse patient effects were reported.
Additional Manufacturer Narrative
One jelco® viavalve® safety iv catheter, an unused sample from the reported lot, was returned for evaluation.Device history records for the lot were evaluated.The customer's reported problem was "dull needle".A review of the quality inspection process was reviewed and considered adequate and correct.Based on the evaluation of the returned sample, there was no evidence of any manufacturing nonconformance.This investigation did not confirm that the product failed to meet the expected performance.

• Brand Name: JELCO® VIAVALVE® SAFETY IV CATHETERS
• 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: 7334432
• Report Number: 3012307300-2018-00574
• Device Sequence Number: 915452
• Product Code: FOZ
• UDI-Device Identifier: 15019517078404
• UDI-Public: 15019517078404
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: Nurse
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 326310
• Device Lot Number: 3386509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1