MAUDE Adverse Event Report: B. BRAUN MEDICAL INC.; SET, ADMINISTRATION, INTRA

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Multiple attempts were made to obtain additional information regarding specific events.At this time, none have been provided.As no sample and/or lot number were provided, further investigation of the complaint is not possible.The actual defective device is valuable tool in investigating the cause of this incident.B.Braun has forwarded this information to internal departments for review and 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.

Event Description

As per medwatch number mw5110742: description: needleless iv connectors are not protected from skin contact or other objects.A study in a us hospital found that 23% of iv-line connectors were contaminated with pathogenic bacteria, despite strict infection control guidelines that included the use of alcohol lined caps (hankins r, majorant od et al.Microbial colonization of intra vascular catheter connectors in hospitalized patients.Am j infection control 2019; 47:1489).This colonization leads to biofilm formation and seeding of the bacteria into the patients bloodstream which results in life threatening central line associated bacteremia (clabsi).The lack of a passive, mechanical shields on needle-less iv connectors renders these class 2 medical devices unnecessarily unsafe and dangerous.Their human factors defective design is further confirmed by the fact that nurses admit to not disinfecting them prior to 3% of all the infusions.Delahanty km, myers fe, ill.Nursing 2009 i.V.Infection control survey report.Nursing 2009;39(12):24-30).The 2020 central line-associated bloodstream infection (clabsl) rate is 0.87 per 1,000 central line days.An infectious diseases expert's estimate is 10,000,000 central line days in the us every year.Over three years, this would entail 261,000 central line-associated bloodstream infections, many deaths, and huge costs.An estimated 7.5 % of these infections can be attributed to suboptimal iv-connector design allowing contamination with pathogenic microorganisms.Such contamination is found in up to 23 % of connectors, where biofilm formation leads to planktonic seeding of the catheter - and whatever clots may form at the catheter tip.Clabsls follow, endangering roughly 59,600 us patients, each of whom falls under the regulatory safety jurisdiction of the fda."avacare".

• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15174399
• MDR Text Key: 305259624
• Report Number: 2523676-2022-00374
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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