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

Catalog Number 326010

Device Problem Difficult to Advance (2920)

Patient Problem Pain (1994)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that this peripheral intravenous catheter would not penetrate the skin without great difficulty.It was noted that the patient experienced pain.No adverse patient effects were reported.

Manufacturer Narrative

Ten unused samples of smiths medical jelco® viavalve® safety iv catheters were returned for analysis.The products were examined with testing for force to advance and force to lock.The samples passed all quality requirements.Based on the evidence there were no discrepancies or anomalies found relevant to complaint.

• Brand Name: JELCO® VIAVALVE® SAFETY IV CATHETERS
• 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): NULL; 201 west queen street; southington CT 06489
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7535018
• MDR Text Key: 109011319
• Report Number: 3012307300-2018-01899
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: 15019517078398
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 326010
• Device Lot Number: 3566527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1