MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; GYNECOLOGICAL LAPAROSCOPIC KIT

Model Number SMA12LSMFG

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

During opening of sterile pack, a tear was noted.Pack removed from operating room.New pack obtained.No cross-contamination.

• Brand Name: CARDINAL HEALTH
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16991977
• MDR Text Key: 315837008
• Report Number: 16991977
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SMA12LSMFG
• Device Catalogue Number: SMA12LSMFG
• Device Lot Number: 964145
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female