MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH SYRINGE; FLUSH SYRINGE, SALINE

Catalog Number 306500

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problems Bacterial Infection (1735); Sepsis (2067)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

The medical device expiration date is unknown as the lot number is unknown.A medwatch was received with three potential devices used in this incident.One device has no catalog number.One device is the suspect device.The third device is from hospira, catalog 409488820.This incident was notified from the fda, ref mw5059301.No customer contact information was included.The state delivering the incident information (maryland) is used as the initial reporter state is unknown.The device manufacture date is unknown as the lot number is unknown.Device evaluation: results- a sample is not available for investigation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Complaint trending review of this product family (catalog 306500) reveals no other complaint for alleged infection.Conclusion- bd was not able to duplicate or confirm the customer's indicated failure mode.Although a sample and/or lot information was not provided, a general review of the plant controls related to cleanroom manufacturing was performed.The investigation included the following: review of media fill results from the past two years: there had been no media fill (process simulation qualification) failures within the past 2 years related to cleanroom operations.Review of environmental monitoring results (specific to elizabethkingia meningoseptica and stenotrophomonas maltophilia): there has been no microbial growth identified as elizabethkingia meningoseptica and stenotrophomonas maltophilia in the past five years.The environmental data review included personnel, hood surface, equipment surfaces and air.Review of complaint from the past two years to see if similar type of complaints were received: there have been no similar complaints received in the past two years.Based on the investigation results to date, an absolute root cause for this incident cannot be determined.One bd investigator also noted the following: from a google search on non-fermenting and elizabethkingia meningoseptica the following indicates these are basic organisms that can be acquired in a hospital setting."nonfermenting gram-negative bacilli (nfgnb) are a taxonomically diverse group of aerobic, nonsporing, bacilli that either do not utilize glucose as a source of energy or utilize it oxidatively.They occur as saprophytes in the environment and some are also found as commensals in the human gut.Nfgnb are known to account for about 15% of all bacterial isolates from a clinical microbiology laboratory.In recent years, due to the liberal and empirical use of antibiotics, nfgnb have emerged as important healthcare-associated pathogens.They have been incriminated in infections, such as, septicemia, meningitis, pneumonia, urinary tract infections (uti), and surgical site infections (ssi).Nfgnb are innately resistant to many antibiotics and are known to produce extended spectrum ss-lactamases and metallo ss-lactamases.There are very few studies from india wherein the various nfgnb, isolated from patients¿ samples, have been identified and their clinical significance assessed.Hence, this study was undertaken to identify the various nonfermenters isolated from patients admitted to our hospital, a tertiary care center, at kolar.The study was also done to assess their clinical significance and antimicrobial susceptibility pattern, and to identify the various healthcare-related infection they cause.List of non-fermenter: acinetobacter bordetella burkholderia legionella moraxella pseudomonas stenotrophomonas there are also included pathogen species like pseudomonas aeruginosa and moraxella catarrhalis.Regarding: elizabethkingia meningoseptica is increasingly being recognized as a pathogen in hospitalized patients.It is a gram-negative, nonfermenting, nonmotile, oxidase positive bacilli growing on enriched media only.It has been isolated from hospital water supplies, sinks, taps, saline solution used for flushing procedures, disinfectants, and medical devices, including feeding tubes, arterial catheters, and respirators.Environmental studies have revealed that the organism can survive in chlorine-treated municipal water supplies, often colonizing sink basins and taps, intubation tubes, humidifiers, incubators for newborns, ice chests and syringes, and has become a potential reservoir for infections in the hospital environment.".

Event Description

It was reported that the patient was seen in the emergency department and transferred to a higher level of care with severe sepsis.Blood cultures were positive for anaerobic nonfermenter, which the reporter's lab identified as stenotrophomonas maltophilia, via chemical analysis.The lab identified the organism as elizabethkingia meningoseptica via molecular analysis.The most recent visit the patient had to the reporter facility was in the outpatient department for a blood transfusion (date not reported).Subsequent similar cases have very little in common except saline flushes.Besides the bd suspect device, one other flush was stocked at the facility.Of note, the submitted medwatch references a device from hospira, catalog 409488820.The reasons for use of the device was reported as iv start and iv flushes.Concomitant medical products were reported as nephron pharmaceuticals ns flush, 10 ml (ndc487930133); acetaminophen 650mg po x1 dose; diphenhydramine 25 mg po x1 dose; leukocyte reduced packed red cells; and ns iv fluids.No further information is available as no reporter contact information was provided.

Manufacturer Narrative

Additional information/device evaluation: bd places the safety and quality of our products as a top priority.On january 28, 2016, the fda medwatch program sent multiple companies a letter(s) stating that a patient who was treated with multiple medications, including 0.9% sodium chloride (normal saline) products from bd and other manufacturers, some tested positive for the organism elizabethkingia.We take any potential issue with our products very seriously and immediately conducted a thorough investigation.We reviewed the past ten years of our environmental monitoring data, sterilization records, and sterility testing reports from the bd pre-filled flush manufacturing facilities and there is no record of this organism ever being found in this product or in the manufacturing facilities.We reviewed the last two years of complaint data and have maintained an industry low complaint rate and found no adverse trend for the bd pre-filled flush syringe.This issue seems to be isolated to (b)(6), however our bd pre-filled flush syringes are shipped worldwide to over 40 countries and approximately 8,000 healthcare facilities within the us alone.Upon review of the existing data, bd has concluded that the elizabethkingia organism did not originate from the bd pre-filled flush product or manufacturing facilities.

• Brand Name: 10 ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH SYRINGE
• Type of Device: FLUSH SYRINGE, SALINE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5477447
• MDR Text Key: 39615057
• Report Number: 2134319-2016-00001
• Device Sequence Number: 0
• Product Code: NGT
• Reporter Country Code: US
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/16/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 306500
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention