MAUDE Adverse Event Report: O&M HALYARD, INC. GORILLA BAG; WRAP, STERILIZATION

Device Problems Device Emits Odor (1425); Defective Component (2292)

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

Event Date 05/11/2020

Event Type  malfunction  

Event Description

Wet sterilization pack; healthmark industries co makes a "gorilla bag" this bag is designed offer extra protection to sterile instrument sets.It states in the ifu that these bags can be sterilized, they don't work, when you open the set it is full of water and a bad smell.On researching this product further it is sold with sterilization parameters, but never went thru 510k process, no clearance can be found and company says they don't need it.How can it not be 510k needed if you give out instructions to steam sterilization, this goes against everything.I have been taught and i have been doing this for 20 years.Please also note it rates this device for 19 pounds of instruments, sterilizers are rated for 17 pounds [old ones] and 25 pounds [new ones] why make a product that doesn't fit sterilizer manufacture ifu's? please follow up on this halyard blue sterilization wrap, cardinal and medline all have 510k why not this product?; dates of use: (b)(6) 2020 - (b)(6) 2020.It was suppose to protect sterile instruments; comes in multiple sizes and code.Fda safety report id# (b)(4).

• Brand Name: GORILLA BAG
• Type of Device: WRAP, STERILIZATION
• Manufacturer (Section D): O&M HALYARD, INC.
• MDR Report Key: 10188867
• MDR Text Key: 196770640
• Report Number: MW5095162
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other