MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES OR SPECIALTY SPONGE, X-RAY DETECTABLE PEANUT SPONGE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7103

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 02/03/2023

Event Type  malfunction  

Event Description

Earlier this week, i submitted a report for sponge packs that were missing a sponge, from lot 302536.Today, we discovered a sponge pack that had an extra sponge from lot 298255.This is a patient safety concern.

• Brand Name: OR SPECIALTY SPONGE, X-RAY DETECTABLE PEANUT SPONGE
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood rd; arden NC 28704
• MDR Report Key: 16452125
• MDR Text Key: 310345111
• Report Number: 16452125
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7103
• Device Catalogue Number: 7103
• Device Lot Number: 298255
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1