MAUDE Adverse Event Report: CAREFREE SURGICAL SPECIALTIES, INC. KITTNER ROLLS; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 1440

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2021

Event Type  malfunction  

Event Description

Operating room reports picking a case and pulled robotic kittner rolls.They are supposed to have 5 per pack.Nurse found x2 packs with only 4 sealed inside and one pack with 6.Rn pulled them from the omnicell.

• Brand Name: KITTNER ROLLS
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CAREFREE SURGICAL SPECIALTIES, INC.; p.o. box 1029; 450 main street; newcastle CA 95658
• MDR Report Key: 12589835
• MDR Text Key: 275165781
• Report Number: 12589835
• Device Sequence Number: 1
• Product Code: GDY
• 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: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1440
• Device Catalogue Number: REF# 15505/25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1