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

Catalog Number 4510097

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).As no sample and no picture was provided, proper investigation on malfunction was not possible.Hence, the complaint is considered as not confirmed.The complaint is only taken to knowledge and filed for statistical purposes.A review of the batch and manufacturing documentation could not be performed, as no batch number has been provided.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): we received a call from an anaesthesist on (b)(6).That an epidural catheter was broken during retrieval after epidural anaesthesia after birth.2.5 cm were left in the patient and the anaesthesist asked if literature is available and gave the information that the patient is fine and had been sent home.

• Brand Name: PERIFIX
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, pa ; 2408332
• MDR Report Key: 9933319
• MDR Text Key: 195908447
• Report Number: 9610825-2020-00082
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2020

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: Health Professional
• Device Catalogue Number: 4510097
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1