MAUDE Adverse Event Report: CARDINAL HEALTH COVIDIEN SKIN PREP PAD WEBCOL 70% ISOPROPYL ALCOHOL; PAD, ALCOHOL, DEVICE DISINFECTANT

Lot Number	21C013862
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Covidien skin prep pad webcol 70% isopropyl alcohol medium sterile has no expiration date on the packaging (neither the box containing the individual packages nor individual packages).Alcohol evaporates over time and the pads may contain a less efficacious bactericide if used after the expiration date.When i asked our product supplier, the response was "please be advised that item# 6818- lot number#: 21c013862 has no expiration date".I feel that this is erroneous and alcohol prep pads do in fact expire.I have opened prep pads that are dried out, and whether that is from evaporation or micro punctures in the packaging i have no idea.

• Brand Name: COVIDIEN SKIN PREP PAD WEBCOL 70% ISOPROPYL ALCOHOL
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 20843704
• Report Number: MW5163110
• Device Sequence Number: 3809630
• Product Code: LKB
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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 Lot Number: 21C013862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown