MAUDE Adverse Event Report: BD/C.R. BARD, INC. BD SURESTEP POST INSERTION FOLEY WIPES AND PDI SANI-HANDS INSTANT HAND SANITIZIN; CATHETER, RETENTION TYPE, BALLOON

Catalog Number DFC100

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

Provon surestep foley care wipes have been repackaged in a way which looks very similar to pdi sani-hands wipes - now in size and product style as well as package color.This change puts caregivers and patients at risk for misusing the products for the wrong task, risking perineal skin integrity were the hand-sanitizing wipes used accidentally.The hand wipes have a high percentage of ethyl alcohol content which would be contraindicated for foley care use.

• Brand Name: BD SURESTEP POST INSERTION FOLEY WIPES AND PDI SANI-HANDS INSTANT HAND SANITIZIN
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BD/C.R. BARD, INC.
• MDR Report Key: 15987953
• MDR Text Key: 305685539
• Report Number: MW5113818
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2022

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 Catalogue Number: DFC100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PDI SANI-HANDS INSTANT HAND SANITIZING WIPES.
• Patient Outcome(s): Other