MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED MICROCLAVE CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problems Biofilm coating in Device (1062); Microbial Contamination of Device (2303)

Patient Problem Sepsis (2067)

Event Date 01/01/2020

Event Type  Death  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If any additional information or findings become available, a supplemental emdr will submitted with this information.Date of death is unknown.Due to a software limitation, a date was required to be entered into this form.

Event Description

A user facility medsun mandatory medwatch report (mw5110742) was received by the manufacturer on 15-jul-2022.A physician licensed in (b)(6) reported that the basic design of needle-free connectors are leading to clasbi (central line bloodstream infections) in patients.The manufacturer(s) of the needle-free connectors was/were not specified with respect to the reported complaint.The customer has provided results of a clinical study that he claims to be in alignment with the reported complaint as follows: ¿needleless iv connectors were 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 patient¿s bloodstream which results in life threatening central line associated bacteremia (clasbi).The lack of a passive, mechanical shield 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 iv infection control survey report.Nursing 2009;39(12):24-30).The 2020 central line-associated bloodstream infection (clasbi) 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.Clasbis follow, endangering roughly 59,600 of us patients, each of whom falls under the regulatory safety jurisdiction of the fda.¿ the customer followed up on 19july2022 with additional information stating at all iv connectors are involved and the problem is not specific to any lot number.The reporting physician stated that his neighbor died from a central line-associated bloodstream infection (clabsi) at a well-known healthcare institution (which he did not have the freedom to name).The patient¿s age was around 65-75, female.Diagnosis: on chemotherapy, for a brain tumor.Chemotherapy administered iv through a central line.Central line associated blood stream infection with multiple resistant organisms (mdr).Hospital-acquired infection.Repeated positive blood cultures were the relevant laboratory test results.It was assumed all routine laboratory results (from (b)(6) hospital in (b)(6)) each indicated an immunocompromised state due to ongoing chemotherapy and a bloodstream infection.The complaining physician was not allowed to reveal the date and time the patient expired since this would identify the patient.Central line associated blood stream infection was the cause of death.Physicians at (b)(6) hospital, (b)(6) made the cause of death determination.The complainant did not know if an autopsy was done.A considerable portion of the thousands of clabsi he reported as saes was caused by the bacterial contamination + human factors (omitted/distracted disinfection in 3%) of needleless iv valve connectors.The complainant stated that he reported > 20,000 severe adverse events (death or prolongation of hospital stay) causally linked to needless iv valve connectors to the fda and its commissioner (b)(6).Other devices attached to the involved device were standard male luer locks, iv lines, central lines, and pic lines.The complainant indicated that he could not provide more information.

Event Description

Additional information was received by the customer on 29-aug-2022 confirming that the device malfunctioned and that the product has a human factors design deficiency that leads to contamination and deadly iv line infection which causes prolongation of hospitalization.It was further confirmed that the mating devices are standard male luer iv connectors.The customer indicated that because these mating devices are usually used fresh from a sterile package (and for short periods of time only), they usually do not get contaminated as frequently as the open meniscus on the icu needleless connectors.

• Brand Name: UNSPECIFIED MICROCLAVE CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15191372
• MDR Text Key: 297513266
• Report Number: 9617594-2022-00230
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• 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
• Treatment: STANDARD MALE LUER LOCKS, MFR UNK.; UNSPECIFIED CENTRAL LINE, MFR UNK.; UNSPECIFIED IV LINE, MFR UNK.; UNSPECIFIED PIC LINE, MFR UNK.
• Patient Outcome(s): Death; Life Threatening; Hospitalization
• Patient Sex: Female