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

Catalog Number 4513150

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).Device history record (dhr): reviewed the dhr for the batch no.18d16g8f01, no abnormalities observed during the in-process and final control inspection.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.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in: (b)(4).Epidural insertion done at l3/l4 level.Catheter advanced without difficulty.Needle pulled out without difficulty.Following which, the catheter had to be adjusted (pulled out) to level 9cm marking and it snapped.

• 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: 9849387
• MDR Text Key: 187419979
• Report Number: 9610825-2020-00062
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: 4513150
• Device Lot Number: 18D16G8F0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• 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
• Patient Outcome(s): Required Intervention