MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; CESAREAN SECTION TRAY

Model Number DYNJ04620R

Device Problem Component Missing (2306)

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

Event Date 11/16/2020

Event Type  malfunction  

Event Description

When staff opened custom c-section pack the 2 blade no.10 were missing.Blades were pulled from stock and c-section proceed without impact to the patient.The rest of the pack was used and is not available.A copy of the packing list is available.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 10918802
• MDR Text Key: 218711473
• Report Number: 10918802
• Device Sequence Number: 1
• Product Code: OHM
• 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: 11/16/2020

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: No Information
• Device Model Number: DYNJ04620R
• Device Catalogue Number: DYNJ04620R
• Device Lot Number: (10) 20HMA750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA
• Patient Weight: 73