MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - LAREDO CYSTO PACK-LF; LAPAROSCOPY KIT

Lot Number (10)22FMI217

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

Cysto pack opened - scrub tech noticed tiny metal shavings on back table; 1 metal shaving saved for risk; pack was broken down and sealed in bag; new pack opened and viewed for contamination; nothing found.No patient in operating room.

• Brand Name: CYSTO PACK-LF
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - LAREDO
• MDR Report Key: 15638489
• MDR Text Key: 302245785
• Report Number: MW5112749
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: (10)22FMI217
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male