MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NEEDLELESS VIAL ACCESS CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number 8881540111

Device Problems Device Contaminated During Manufacture or Shipping (2969); Protective Measures Problem (3015)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

Unknown substance in sterile packaging.Needless cannula med prep from cardinal health.Our clinicians noticed it prior to using it, however, just because it is visible on one item does not mean this it is visible on other products within the lot which raises a serious safety concern as to the sterility of the prep cannula.Note, i attempted to report this to the company and requested an opportunity to return the product to the manufacturer.They responded they are unable to process it without the account number of our facility which i didn't know.I didn't think it was legal for a medical company to refuse a complaint that poses a safety threat to the consumer regardless of what information i have or don't have.

• Brand Name: NEEDLELESS VIAL ACCESS CANNULA
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 17039821
• MDR Text Key: 316444057
• Report Number: MW5118024
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8881540111
• Device Lot Number: 23C112
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1