MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP (NORTHPOINT SERVICES) MEDLINE PLASTIC BASIN PACK; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number DYNJ63883C

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

Plastic basin sterile procedure pack was opened, and nurse reported that wood chips or cardboard pieces were in the pack.Pack was not used and returned to vendor.

• Brand Name: MEDLINE PLASTIC BASIN PACK
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP (NORTHPOINT SERVICES); northfield IL 60093
• MDR Report Key: 16279021
• MDR Text Key: 308651964
• Report Number: MW5114618
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ63883C
• Device Catalogue Number: DYNJ63883C
• Device Lot Number: 22JDC142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1