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

Catalog Number 4454410

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received 6 pictures of a perifix catheter and one picture of the primary packaging, no sample.The pictures show a perifix catheter were the catheter tip is missing (approx.10 - 20 mm from the tip).Based on the pictures the surface of the demolition site is not clearly visible.It can only be seen that the catheter has been sheared off obliquely.We received no picture of the sheared part of the catheter tip.Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off." therefore we assume a fault during the application process and we consider the complaint as not confirmed.We exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are sold in the united sates by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): broken off a piece of the catheter is broken off and a piece is still inside the patient.

• 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: 10000371
• MDR Text Key: 190680674
• Report Number: 9610825-2020-00096
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Catalogue Number: 4454410
• Device Lot Number: 19M21A8001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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