MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC UPMC HAMOT KIT, HMT LARAROSCOPY; LAPAROSCOPY KIT

Catalog Number PG4ELAHTB

Patient Problem Insufficient Information (4580)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

Upon opening the pack, scrub tech noticed plastic piece on table cover.

• Brand Name: UPMC HAMOT KIT, HMT LARAROSCOPY
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 18239448
• MDR Text Key: 329481619
• Report Number: MW5148594
• 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: Other
• Type of Report: Initial
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PG4ELAHTB
• Device Lot Number: 134486
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1