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

Model Number 326010

Device Problems Difficult to Insert (1316); Dull, Blunt (2407)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information received on 19-oct-2022.

Event Description

It was reported that when administering i.V.Nutrients to patients, the needles seem to be more dull than usual.The number of patients is not known.None of the patients were harmed or required any medical attention.They were needing to apply more pressure to puncture the skin.Additional information received on 19-oct-2022 via email and attached to the complaint object: the events occurred over (b)(6) (for every client, every time).No patients were harmed; no labs were drawn; no medical intervention was required.The catheters act as if they were more dull than others.Upon switching to a different model of catheter, all problems ceased.

Manufacturer Narrative

The complainant returned two hundred (200) unopened, unused samples for evaluation.Twenty random samples of the returned product were visually evaluated and tested for penetration.All samples were found to be acceptable.Based on the sample review, the reported event could not be confirmed as a manufacturing related nonconformance.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored and analyzed for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.(h6c, h6d, h6e).

• Brand Name: VIAVALVE SAFETY IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15679573
• MDR Text Key: 307014951
• Report Number: 3012307300-2022-26334
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019517078398
• UDI-Public: 15019517078398
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/17/2024
• Device Model Number: 326010
• Device Catalogue Number: 326010
• Device Lot Number: 4266516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1