MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SAFETY VIAVALVE CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number 326610

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

One 20g viavalve catheter assembly, without sheath, needle guard assembly and blister packaging, was returned for analysis.Initial visual examination of the sample confirmed that there was no catheter tube present.Magnified examination of the sample also displayed evidence of damage to the catheter hub nose od, consistent with scissors inadvertently cutting against the hub.Additionally, visual examination of the seal component displayed no evidence of actuation.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

Event Description

It was reported that a when the customer removed saline lock of a smiths medical catheter no cathlon was noted on the end.Patient was examined via x-ray in effort to locate catheter piece.No piece was found and no further treatment was needed.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: JELCO SAFETY VIAVALVE CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11817266
• MDR Text Key: 250368471
• Report Number: 3012307300-2021-04293
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078428
• UDI-Public: 15019517078428
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: 326610
• Device Catalogue Number: 326610
• Device Lot Number: 3995085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1