MAUDE Adverse Event Report: PACK ROOM LLC HUNTSVILLE MINOR; LAPAROSCOPY KIT

Model Number HH130

Device Problem Component Missing (2306)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

Or (operating room) received and opened two minor packs that did not have any raytex sponges in the packs.Could have led to a delay in a procedure if one had been started and/or patient was on the operating room table.

• Brand Name: HUNTSVILLE MINOR
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): PACK ROOM LLC; 1281 highway 155 south; mc donough GA 30253
• MDR Report Key: 16120516
• MDR Text Key: 306890380
• Report Number: 16120516
• Device Sequence Number: 1
• Product Code: FDE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/02/2023

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 Model Number: HH130
• Device Catalogue Number: HH130.003
• Device Lot Number: 33245
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1