MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CIRCUMCISION TRAY

Lot Number 505770

Device Problems Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583); Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/07/2023

Event Type  malfunction  

Event Description

Dr approached staff with concerns regarding new circumcision kits.Items in the kit, that do not require donning sterile gloves but due to the new packaging they have to be done with the sterile gloves.Straps are not as good.The syringe pump pops off when using.Scissors are too big and don't work the best, they are clunky.The blade is too big.There wasn't enough betadine in the swab packs.

• Brand Name: CIRCUMCISION TRAY
• Type of Device: CIRCUMCISION TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17125245
• MDR Text Key: 317141254
• Report Number: 17125245
• Device Sequence Number: 1
• Product Code: OHG
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 505770
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1