MAUDE Adverse Event Report: CAREFUSION FINLAND 320 OY VITAL SIGNS; ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR

Model Number 7000AAO

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/04/2021

Event Type  malfunction  

Event Description

The physician noted and she had to pull this through the uterus attached to the fetal scalp and was unable to remove it prior to the surgery.During labor she had placed a second one, and referred to the one she could not remove as the "extra fse." it is unclear who removed it after delivery based on documentation.

• Brand Name: VITAL SIGNS
• Type of Device: ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR
• Manufacturer (Section D): CAREFUSION FINLAND 320 OY; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 12048885
• MDR Text Key: 257737822
• Report Number: 12048885
• Device Sequence Number: 1
• Product Code: HGP
• UDI-Device Identifier: 10885403248962
• UDI-Public: (01)10885403248962
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7000AAO
• Device Catalogue Number: 7000AAO
• Device Lot Number: S13191-F
• 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: 06/07/2021
• Date Report to Manufacturer: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA