MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - LAREDO MEDLINE C-SECTION PACK; CESAREAN SECTION TRAY

Model Number DYN70604460AF

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

Event Date 09/18/2023

Event Type  Injury  

Event Description

The c/section(cesarean section) medline pack usually contains 4 undetectable gauzes for pre-incision/post closure use.Instead, 40 undetectable gauzes are in these packs.These gauzes are not detectable by x-ray or by our rifd(radio frequency identification) machine.The volume of gauze does not match the content list.These gauzes could be mistakenly used and left in the body cavity; with no means to detect that they were left inside the body.Issues identified prior to use on patients.Believe it to be identified at all pds sites with no patient impact at this time.

• Brand Name: MEDLINE C-SECTION PACK
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - LAREDO
• MDR Report Key: 17877431
• MDR Text Key: 325076085
• Report Number: MW5146610
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYN70604460AF
• Device Lot Number: 23AMF239
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention