MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - LAREDO MEDLINE CUSTOM OR PACKS; GENERAL SURGERY TRAY

Lot Number	24DBA579
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) operating room have discovered a significant number of contaminated medline industries, lp custom operating room packs.The contamination ranges from black and red particulates, hair, skin tissue, piece of red painted fingernail and eye lashes - among other contaminants.On may 17th, 2024 - medline was notified of our particulate quality concerns.Since that time - the frequency of contaminated packs has grown considerable.To date - we have identified 182 contaminated custom operating room packs.This has been reported to the medline.In previous quarters - there we 3-8 contaminated custom operating room packs per quarter reported, compared 182 contaminated custom operating packs reported.This poses a patient safety risk for patients.There is potential for surgical site infections if the contamination is not identified when the pack is being opened in the sterile environment.This also causes a delay in emergent cases as multiples packs may need to be opened and the entire sterile field may need to be taken down.We have included the lot numbers for the custom packs.Reference reports: mw5156579, mw5156580, mw5156581, mw5156582, mw5156583, mw5156584, mw5156585, mw5156586, mw5156587, mw5156588, mw5156589, mw5156590, mw5156591, mw5156592, mw5156593, mw5156594, mw5156595, mw5156596, mw5156597, mw5156598, mw5156600, mw5156601, mw5156602, mw5156603, mw5156604, mw5156605, mw5156606, mw5156607, mw5156608.

• Brand Name: MEDLINE CUSTOM OR PACKS
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - LAREDO
• MDR Report Key: 19615389
• Report Number: MW5156599
• Device Sequence Number: 6983470
• Product Code: LRO
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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
• Device Lot Number: 24DBA579
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown