MAUDE Adverse Event Report: BD NEEDLELESS IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Product Quality Problem (1506); Use of Device Problem (1670); Connection Problem (2900); No Fail-Safe Mechanism (2990)

Patient Problem Bacterial Infection (1735)

Event Date 01/01/2020

Event Type  Injury  

Event 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".

• Brand Name: NEEDLELESS IV CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD
• MDR Report Key: 14957020
• MDR Text Key: 295607217
• Report Number: MW5110742
• Device Sequence Number: 6
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2022
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: A CENTRAL LINE OR ; A PIC LINE.; AN IV LINE, ; DRUGS WHERE THE DISEASE OR THE CONDITION OF A PT NECESSITATE ADMINISTRATION THROUGH AND; MULTIPLE THAT ALL NECESSITATE INFUSION THROUGH A CENTRAL LINE BUT ARE NOT RELATED TO LINE INFECTIONS.
• Patient Outcome(s): Other; Hospitalization; Life Threatening; Required Intervention