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 Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun (b)(4) internal report # (b)(4).We only received one picture of a used perifix periduralkath.20g soft tip connected with a perifix cath.Con.2.1 out of a perifix-soft-tip 701 set 18g filter lor.Although the batch number was reported as unknown, the user facility did provide the following batch numbers that are in use at the facility: 19n02a8701 / 19m12a8701.The following investigations were conducted: visual inspection: the received picture was taken to a visual inspection for damages according to the test method.Definition of the method: damages are visible changes in the original shape or surface of products and packaging caused by mechanical forces and/or manufacturing faults.Nominal: no damage is allowed that endangers the patient, impedes the use of the part as intended (e.G.The impairment of the function of a drop sensor), endangers the assembly or function of the component or impairs the appearance of the component.Actual: the catheter is cut off, the cut off part of the catheter is not visible at the customer picture.Summary and assessment: we exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.Because of this we assume of a problem during the application process.Based on the conducted investigations the checked sample is within the specification.Therefore the complaint is considered as not confirmed.The complaint is only taken to knowledge and filed for statistical purposes.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states 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)): when the catheter has been removed, a part has remained in the patient.Scan result 17th march: absence of foreign body in the spinal canal.X ray picture requested.

• 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: 9985925
• MDR Text Key: 188651812
• Report Number: 9610825-2020-00095
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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: 03/25/2020
• Initial Date FDA Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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