MAUDE Adverse Event Report: ROI CPS, LLC REGARD; MINOR PACK

Model Number	GS00085AD
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A hole was discovered in the vented bag.
Additional Manufacturer Narrative
A site visit to the facility who reported this event was conducted after roi cps, llc identified that kits, that had been 100% inspected for damages prior to shipment, were the same kit lot number involved in this complaint.The inspection conducted by our firm confirmed that there were no damages to the vented bags prior to the kits leaving the our firm and arriving at the end user facility.During the site visit, roi cps, llc kits were observed from receiving, through handling, storeing, and use of the kits, with end user facility personnel present.The conclusions drawn from the visit and the recommendations to the facility are attached.
Event or Problem Description
A hole was discovered in the vented bag.
Additional Manufacturer Narrative
A site visit to the facility who reported this event was conducted after roi cps, llc identified that kits, that had been 100% inspected for damages prior to shipment, were the same kit lot number involved in this complaint.The inspection conducted by our firm confirmed that there were no damages to the vented bags prior to the kits leaving the our firm and arriving at the end user facility.During the site visit, roi cps, llc kits were observed from receiving, through handling, storing, and use of the kits, with end user facility personnel present.The conclusions drawn from the visit and the recommendations to the facility are attached.On (b)(6) 2024 roi cps, llc received an email communication from the user facility where this kit is stored that outlined their findings at the facility related to the root cause of the damage to kits stored at the user facility.The communication from the facility is as follows: we may have discovered a source of the snags on the minor packs.Along the outer edge of the metro shelves housing the minor packs is a blue strip that is for labels/ tags to be attached to the shelf.We don't use them however three of the approx.10 carts in the case cart area have these strips.Two of the carts contain non pack items that would not be in contact with these strips.The only packs to be stocked on these particular carts are minor packs that are housed on one cart.By happen stance one of the packs got noticeably snagged by this shelf strip.It made a loud noise that caught the attention of the case cart builder.In closer examination the bottom two shelf strips were rather jagged when you ran your finger over it.Because it was the bottom two shelf's it was not visually noticeable.However, it was pronounced enough that i think it may be the source of the problem.99% of the issues we are having are minor packs and this discovery is the only differentiator that i can see between minor and other packs.I think having the basin in the pack has made it more vulnerable to the rough edges like the ones on these two shelves.Strips have been removed.
Event or Problem Description
A hole was discovered in the vented bag.

• Brand Name: REGARD
• Common Device Name: MINOR PACK
• Manufacturer (Section D): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic MO 65738
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, MO 65738 ; 4176473205
• MDR Report Key: 18746864
• Report Number: 3014527682-2024-00005
• Device Sequence Number: 3740860
• Product Code: LRO
• UDI-Device Identifier: 10194717116202
• UDI-Public: 10194717116202
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

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
• Operator of Device: Other
• Device Expiration Date: 11/05/2025
• Device Model Number: GS00085AD
• Device Catalogue Number: 880085030
• Device Lot Number: 98644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 01/24/2024; 01/24/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 02/23/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown