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

Model Number 326010

Device Problem Disconnection (1171)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the catheter spring released causing the saline-flush syringe that was luer locked into the hub, to become disconnected and flew onto the stretcher; blood also flowed from the iv until the rn's were able to secure it.

Manufacturer Narrative

Device available for evaluation; h3.Device evaluated by manufacturer and h6.Health impact, event problem and evaluation codes: updated.Received twelve (12) unused samples from the same lot number, three (3) from a different lot number not mentioned in the complaint, and one used, locked out needle guard and catheter assembly with sheath component and without blister packaging from an unknown lot number for analysis.The unused samples were evaluated for luer lock and were found to be acceptable with no failures.The used sample was visually examined for any potential related issues such as excessive presence pooled seal lubricant or any manufacturing related damages to the catheter hub.In addition, the used sample was evaluated for luer lock and the used sample was found to be acceptable.The complaint could not be confirmed.A device history record (dhr) review found no reports of abnormalities or discrepancies during the manufacturing of the reported lot number.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Icu medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.

• Brand Name: JELCO VIAVALVE SAFETY I.V. CATHETER
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16218391
• MDR Text Key: 307832014
• Report Number: 3012307300-2023-00600
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 326010
• Device Catalogue Number: 326010
• Device Lot Number: 4305696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention