MAUDE Adverse Event Report: NULL JELCO SAFETY VIAVALVE CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Device Problem Defective Component (2292)

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

Event Date 04/19/2022

Event Type  malfunction  

Event Description

It was reported that the valve is not working on some of the iv catheters.Last evening 3 of the staff had the valve fail.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Complainant returned one used, locked-out 20g viavalve needle guard assembly, without catheter assembly, sheath and blister packaging, for analysis.The sample was visually examined under magnification for any potentially related nonconformances.The sample displayed normal flash in the flashback chamber with evidence of blood pooling inside the guard and nose ids, as well as dried blood residue in the end cap id and on the nose od.There was also no evidence of any cannula o.D.Or nose i.D.Gaping noted that could potentially result in leakage.Blood pooling as noted during visual examination is indicative of an issue during use.It should be noted that during use, the valve is not intended to prevent backflow of blood in the guard.Without the catheter assembly for the returned sample to evaluate for potential valve functionality issues, the complaint cannot be confirmed as the result of a manufacturing nonconformance.No discrepancies or abnormalities relevant to the complaint.The cause of the reported problem could not be determined.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-09513.The report was submitted in error., corrected data: corrected information provided in h10.

• Brand Name: JELCO SAFETY VIAVALVE CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section G): NULL
• MDR Report Key: 14493416
• MDR Text Key: 292587259
• Report Number: 3012307300-2022-09513
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1218-2019 Z-0789-2017
• Patient Sequence Number: 1