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

Catalog Number 4514017C

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/20/2020

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).We received one picture of a used perifix one 0,84mm (20g) 80mm p out of a perifix one 401 filter set without packaging.The picture shows that the perifix catheter is shorn off.The shorn off area is slanted and shows a smooth structure.Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Please see instructions for use: never pull the catheter through the needle as it may otherwise shear off."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)(4)): catheter-damaged-broken.The catheter has broked during placement, ruptured at 7cm and couldn't be recovered.Need to place another catheter.There is also possible harm to the patient, such as pain and potential surinfection.

• 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: 10189534
• MDR Text Key: 196281221
• Report Number: 9610825-2020-00124
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/24/2020

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 Catalogue Number: 4514017C
• Device Lot Number: 19M20A8701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• 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