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

Model Number 328600

Device Problems Disconnection (1171); Material Separation (1562)

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

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.

Event Description

It was reported that while using a number 20 iv on a patient, the needle retracted causing the pink hub to fall to the floor without the tubing.The customer instantly applied pressure to the blood vessel a few inches above the insertion site, in the event that the plastic tubing was in the patient's arm.Customer called the dr.Over immediately to do an ultrasound of the arm to ensure the plastic tubing was not in the patient's arm floating unattached.There was no evidence of the tubing on the ultrasound or xray.On palpation, customer couldn't feel any foreign objects either.The missing piece was never located.Patient is fine as of this moment, and is aware to notify staff if they notice any pain, or soreness, shortness of breath (sob).No patient injury reported.

Manufacturer Narrative

Device evaluation: 5 unused, unopened devices and one used catheter assembly with severed tube and without needle assembly, sheath, and blister packaging were received for analysis.The unused sister samples were evaluated for catheter to tip deformation, tube tears, and catheter security and were found to be acceptable without any failures.The used sample did not display evidence of catheter hub damage or actuator-to-tube securement issues.Upon magnified examination, the sample displayed evidence of a catheter severance above the hub nose, with a partial smooth cut at the point of severance.The other end of the tubing displayed evidence of the material being elongated due to force.The complaint was confirmed.Based on what was returned, there were no mechanical witness marks on the catheter hub.Additionally, since it was reported that there was an involvement of the patient bleeding and the severed tube gone missing, this indicates that the catheter had been inserted into the vein prior to the detection of any catheter severance, and that there was no initial indication of any damage upon the device prior to use.Review of device history records (dhr) and manufacturing logbooks did not indicate any definite root cause for the reported issue.The review verified that all routine controls were executed properly in a timely manner.No correction or corrective actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.

• Brand Name: JELCO VIAVALVE SAFETY I.V. CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16880136
• MDR Text Key: 314673964
• Report Number: 3012307300-2023-05226
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688081957
• UDI-Public: 10351688081957
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 328600
• Device Catalogue Number: 328600
• Device Lot Number: 4351357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2022
• 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