FDA Adverse Event Malfunction Summary report: N

PRECISION TOUCH ICE BOSMA

MDR report key: 23541948 · Received November 12, 2025

Report

Report Number
MW5178794
Event Type
Malfunction
Date Received
November 12, 2025
Date of Event
November 4, 2025
Report Date
November 9, 2025
Manufacturer
MEDLINE INDUSTRIES, LP - NORTHFIELD
Product Code
LZA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WI, US
Reporter Occupation
PHARMACIST
Health Professional
Yes

Narratives

Description of Event or Problem · 0

GLOVES ARE COMING OUT OF BOX WITH CUFFS FUSED TOGETHER, RIPPED, TEARING. - 200 COUNT BOX OF BOSMA ENTERPRISES - PRECISION TOUCH ICE SIZE SMALL PRECISION TOUCH ICE POWDER FREE NITRILE EXAM GLOVES NOTED TO BE DEFECTIVE. THE 5+ GLOVES THAT WERE REMOVED FROM THE BOX WERE NOTED TO BE THIN AND TORE WHEN ATTEMPTED TO PUT ON. - GLOVES PACKED SO TIGHT INTO THE BOX THAT MULTIPLE GLOVES FELL ONTO THE FLOOR WHEN TRYING TO REMOVE A SINGLE GLOVE. IN ADDITION TO THE LOSS OF GLOVES TO THE FLOOR, 3 GLOVES REMOVED WERE ALREADY RIPPED AND ANOTHER GLOVE RIPPED WHILE DONNING. IT ALSO TAKES AN UNNECESSARY AMOUNT OF TIME TO DON THE GLOVES DUE TO THE SUFFOCATING PACKAGING -NEW GLOVES EASILY RIP AND VERY THIN. DELAYED CARE DUE TO CONSTANTLY PULLING NEW GLOVES BECAUSE THEY ARE ALL STICKING TO EACH OTHER AND THEN RIPS OR THE EDGE OF THE GLOVES FALL APART, AND POOR QUALITY AS I SLIDE MY HAND IN, IT RIPS. RISK FOR FLUID CONTAMINATION TO STAFF. - I HAVE APPLIED THE NEW PRECISION TOUCH ICE GLOVES SIZE SMALL ALL DAY TODAY IN SEVERAL ROOMS. EVERY GLOVE I INITIALLY PUT ON RIPPED. I HAD TO GO THROUGH 1-3 PAIRS BEFORE I GOT ONE THAT DID NOT RIP. THEY ARE STUFFED IN THE BOXES SO TIGHT THAT WHEN YOU PULL A GLOVE OUT, THEY ARE STICKING TOGETHER. WHEN YOU PULL THE GLOVES APART TO PUT YOUR HAND IN, THEY RIP. -THE GLOVES PROVIDED ARE NOT OSHA STANDARD. THE GLOVES BREAK DURING DONNING AND DURING DIRECT PATIENT CARE WHERE FLUIDS ARE BEING DEALT WITH. - ISSUE WITH NEW GLOVES: THROUGHOUT TOUR MULTIPLE PAIRS OF GLOVES TORE UPON ATTEMPTS TO SEPARATE AT WRIST, WHERE THE OPENING SHOULD BE. MANY GLOVES APPEAR TO BE STUCK/MELTED/FUSED TOGETHER AT THE WRIST END. ALSO, MULTIPLE GLOVES TORE WITH ATTEMPT TO DON. THESE GLOVES ARE BRITTLE AND THE GLOVE BOXES ARE PACKED SO TIGHT INITIALLY, IT IS EXTREMELY DIFFICULT TO REMOVE THE FIRST 10-20PAIRS WITHOUT DAMAGING THE BOX OR THE GLOVES THEMSELVES. -WENT TO GRAB A PAIR OF GLOVES FROM THE NEW SUPPLY OF GLOVES, BOSMA PRECISION TOUCH ICE, AND THEY TORE WHILE I WAS PLACING THEM ON MY HANDS. PT CODE: 4582. DEVICE CODE:1069, 2284. REF REPORTS: MW5178793 AND MW5178795.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1984259 PRECISION TOUCH ICE BOSMA POLYMER PATIENT EXAMINATION GLOVE LZA MEDLINE INDUSTRIES, LP - NORTHFIELD 73-20502 4518686929MD

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown