MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH CRANIOTOMY PACK; NEUROLOGICAL TRAY

Model Number	SNE13CR602
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: in the last two days, we have discovered a total of 15 cardinal surgical packs that had foreign objects in some part of the pack.These packs were all deemed as contaminated.The type of packs are spine packs, lower extremity pack, craniotomy pack and arthroscopy pack.At times, we opened multiple of the same packs only to find that each of them was contaminated.Due to this, we stopped opening packs in hopes of finding one not contaminated and instead had spd [sterile processing department] sterile core just pick the single sterile items that would otherwise be in the pack.This delayed us significantly.Of particular note is that during setup for an emergent class a craniotomy this morning, we opened four packs that were deemed contaminated.Due to this case being time critical, we moved to picking individual sterile supply items for the case.Some of the items deemed contaminated were thrown out but some have been retained by the operating room.Manufacturer response for arthroscopy pack, (brand not provided) (per site reporter).Reps [redacted] and [redacted] have been made aware.On site [redacted] and [redacted].Manufacturer response for neurological tray, cardinal health (per site reporter).Reps [redacted] and [redacted] have been made aware.On site [redacted] and [redacted].Manufacturer response for neurological tray, cardinal health (per site reporter).Reps [redacted] and [redacted] have been made aware.On site [redacted] and [redacted].

• Brand Name: CARDINAL HEALTH CRANIOTOMY PACK
• Common Device Name: NEUROLOGICAL TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 21890507
• Report Number: 21890507
• Device Sequence Number: 19715303
• Product Code: OJG
• UDI-Device Identifier: 10197106862094
• UDI-Public: (01)10197106862094
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2025
• Report Date (Section F): 04/17/2025

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 Model Number: SNE13CR602
• Device Catalogue Number: SNE13CR602
• Device Lot Number: 406312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/17/2025