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

Catalog Number 15505/25

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 04/12/2022

Event Type  malfunction  

Event Description

Operating room reports that when opening kittner rolls gauze for a case, the scrub tech took rolls and counted six.Package is only to contain five rolls.The package of six was removed from the field.

• Brand Name: KITTNER ROLLS
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): CAREFREE SURGICAL SPECIALTIES, INC.; 1123 12th ave rd. ste.341; nampa ID 83686
• MDR Report Key: 14310991
• MDR Text Key: 290959985
• Report Number: 14310991
• 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: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 15505/25
• Device Lot Number: 1489
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1