MAUDE Adverse Event Report: DYAD ENTERPRISE LLC HCS; APPLICATOR, ABSORBENT TIPPED, STERILE

Lot Number 190913

Device Problem Defective Device (2588)

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

Event Date 08/12/2020

Event Type  malfunction  

Event Description

Opened alcohol swab to clean off vial of insulin to draw up insulin on pt.The alcohol swab inside packaging was completely dry.Manufacturer response for alcohol prep, hcs (per site reporter).Defective product form sent to vendor.

• Brand Name: HCS
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): DYAD ENTERPRISE LLC; 625 clark avenue suite 16; king of prussia PA 19406
• MDR Report Key: 10553120
• MDR Text Key: 207515083
• Report Number: 10553120
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 190913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1