MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX EPIDURAL CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2020

Event Type  Injury  

Event Description

Retained foreign object.Epidural catheter removed after vaginal delivery.Blue tip of catheter not intact.Rn looked at tip immediately after removal.Neurosurgery saw while patient was still admitted.Ct of lumbar/thoracic spine did not show fragment.Patient will have an mri of spine in 3 months followed by a follow up appointment with neurosurgery.Fda safety report id# (b)(4).

• Brand Name: PERIFIX EPIDURAL CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 10028396
• MDR Text Key: 190180364
• Report Number: MW5094384
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 75