MAUDE Adverse Event Report: HAND SQUEEZE DEVICE

Device Problems Device Reprocessing Problem (1091); Device Contamination with Body Fluid (2317)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

I was recently donating blood at the blood center in (b)(6), when i noticed the squeeze products used had blood droplets on them as if they were not sterilized or cleaned after each donor.This product was made of a sponge material in which blood probably saturates if not cleaned properly.I believe this product is very harmful from person to person.

• Brand Name: HAND SQUEEZE DEVICE
• Type of Device: HAND SQUEEZE DEVICE
• MDR Report Key: 4174116
• MDR Text Key: 5162422
• Report Number: MW5038557
• Device Sequence Number: 1
• Product Code: ION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1