MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC BILICHEK DISPOSABLE CALIBRATION TIP; BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM

Catalog Number B800-50

Device Problems Fitting Problem (2183); Defective Component (2292)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

Bilichek disposable calibration tip would not fit into bilichek machine.Noted that component has defective prongs that don't line up with machine.

• Brand Name: BILICHEK DISPOSABLE CALIBRATION TIP
• Type of Device: BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 222 jacobs street; cambridge MA 02141
• MDR Report Key: 16708600
• MDR Text Key: 312970710
• Report Number: 16708600
• Device Sequence Number: 1
• Product Code: MQM
• 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: 03/24/2023

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 Catalogue Number: B800-50
• Device Lot Number: K09012201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1