MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX®; ANESTHESIA CONDUCTION KIT

Model Number 332152

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

As reported by the user facility: event 2: detailed inquiry description end user indicated there is a film on the syringes.It's a very fine film, like a powder.This film/powder is inside the barrel of the syringe as well.When the syringe plunger is pressed you can see a line inside the syringe of the film/powder.No patient involvement.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

Event 2: this report has been identified as b.Braun medical internal report number 400550232.Two (2) photos and several unopened samples were provided for further evaluation.Visual evaluation of the photos and samples were found to meet specification.Although there was a slight frosty/cloudy appearance to the rollstock, it is normal for this type of packaging material to appear this way.The returned product was evaluated and confirmed to meet specification.Retained units were evaluated and passed the internal testing.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: PERIFIX®
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14137100
• MDR Text Key: 289461367
• Report Number: 2523676-2022-00154
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 04046964177620
• UDI-Public: (01)04046964177620
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 332152
• Device Catalogue Number: 332152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1