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

Model Number DYNJ63883C

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 03/06/2023

Event Type  malfunction  

Event Description

Dead bug found inside the medline sterile plastic basin pack while preparing for case in the operating room.Entire kit was torn down and disposed of upon discovery.Entire set-up was disassembled, re-picked, and reassembled.Could have contaminated the entire set-up for case.

• Brand Name: MEDLINE STERILE PLASTIC BASIN PACK
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP (NORTHPOINT SERVICES)
• MDR Report Key: 16537264
• MDR Text Key: 311319830
• Report Number: MW5115724
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• 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: 42981-DNQ BFC CVR TBL 80X110 H
• Device Lot Number: 22JDC142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1