MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Model Number CE17TKFC

Device Problems Break (1069); Unraveled Material (1664)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

The catheter became unwound and subsequently broke.Happened outside the patient body.

• Brand Name: PERIFIX FX CONTINUOUS EPIDURAL ANESTHESIA CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 13280096
• MDR Text Key: 283950781
• Report Number: 13280096
• Device Sequence Number: 1
• Product Code: BSO
• 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: 01/11/2022

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 Model Number: CE17TKFC
• Device Catalogue Number: CE17TKFC
• 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: 01/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10220 DA
• Patient Sex: Female
• Patient Weight: 89 KG