MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PENCAN; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 333851

Device Problem Insufficient Information (3190)

Patient Problems Incompetent Cervix (1927); Pain (1994)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

Female patient in labor & delivery ward presented with cervical incompetence, antepartum; and had a previous cesarean delivery.During the cerclage placement, the anesthesiologist used spinal tray but the patient did not have adequate pain relief following spinal anesthesia.Later, iv sedation was required in order to complete the cerclage placement.

• Brand Name: PENCAN
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 824 twelfth avenue; bethlehem PA 18018 352
• MDR Report Key: 3758550
• MDR Text Key: 4419385
• Report Number: 3758550
• Device Sequence Number: 1
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/09/2014

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: Physician
• Device Catalogue Number: 333851
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2014
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2014
• Patient Sequence Number: 1
• Treatment: PRENATAL MEDICATION
• Patient Age: 27 YR
• Patient Weight: 64