MAUDE Adverse Event Report: CARDINAL HEALTH / CARDINAL HEALTH 200, LLC HAMOT MINOR VAGINAL PACK; GYNECOLOGICAL LAPAROSCOPIC KIT

Catalog Number	SMA4EMVHTB
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When opening for a surgical case it was noted that a wood chip like item was found in a sterile pack - making it not sterile, new pack was obtained.

• Brand Name: HAMOT MINOR VAGINAL PACK
• Common Device Name: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): CARDINAL HEALTH / CARDINAL HEALTH 200, LLC
• MDR Report Key: 18257733
• Report Number: MW5148708
• Device Sequence Number: 7691355
• Product Code: OHD
• UDI-Device Identifier: 10197106373620
• UDI-Public: (01)10197106373620
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

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 Catalogue Number: SMA4EMVHTB
• Device Lot Number: 148930
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown