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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Sepsis (2067)

Event Date 02/22/2016

Event Type  Death  

Manufacturer Narrative

Date of death: date of death was not included on medwatch form.The date of event is used.The medwatch was received with five potential saline flushes in stock at the reporting facility.(b)(4) has been identified as a hospira worldwide inc device.(b)(4) has been identified as a nephron pharmaceuticals device.The following catalog numbers reflect bd devices: nhric# 8290-306546, 10 ml fill in 10 ml diameter bd posiflush¿ normal saline filled syringe, 510(k)# k003553; nhric# 8290-306500, 10 ml fill in 10 ml bd¿ pre-filled normal saline filled flush syringe, 510(k)# k011982; nhric# 8290-306518, 10 ml fill in 10 ml bd¿ pre-filled normal saline filled flush syringe, 510(k)# k011982.As the devices are manufactured at 2 different locations, and the exact device used in this incident is unknown, (b)(4) has been used as the manufacturing location.Catalog 306500 and 306518 are manufactured in (b)(4); catalog 306546 is manufactured in (b)(4).The medical device expiration dates are unknown as the lot numbers are unknown.This incident was notified from the fda, ref mw5059310.No customer contact information was included.The state delivering the incident information (b)(6) is used as the initial reporter state is unknown.The device manufacture dates are unknown as the lot numbers are unknown.Device evaluation re: catalog 306500 and 306518.Results- a sample is not available for investigation.A review of the device history record cannot be completed as the lot numbers were not provided for this incident.No manufacturing/ equipment/pm/calibration review could be performed as manufacture date is unknown.Conclusion- 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.No media fill syringes were found to have elizabethkingia contamination.The syringe manufacture process as well as the cleanroom associates and cleanrooms are requalified semi-annually.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 within the (b)(4) plant which started manufacturing the flush syringes in 1998.The environmental data review included personnel, hood surface, equipment surfaces, air, sterility testing results and media fill results.Thorough environmental monitoring of the manufacturing environment is performed daily.Endotoxin and sterility testing: performed on each batch of product manufactured in the (b)(4) plant.There have been no endotoxin failures within the past five years and no sterility failures related to elizabethkingia contamination.Bd was not able to duplicate or confirm the customer's indicated failure mode.Based on the investigation results to date, an absolute root cause for this incident cannot be determined.However upon review of the existing data, bd does not feel that the elizabethkingia organism originated from the bd pre-filled flush product or manufacturing facility.Based on an evaluation of frequency and lack of information (lot #, manufacture date, etc) it was determined that no corrective action is required at this time.Device evaluation re: catalog 306546.Result - 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.Posiflush sp history has been verified finding no records for similar issue.Our manufacturing records for 2005 to date show that none of the following organisms have been detected during our site monitoring activities: acinetobacter, bordetella, burkholderia, legionella, moraxella, pseudomonas, stenotrophomonas, and elizabethkingia.The following controls are in place at the manufacturing site: bioburden tested on a weekly basis.An overkill sterilization process is used.Environmental testing within the filling area is done on a biweekly basis.The sterilization process is challenged and re-qualified annually.The solution is filtered twice before it is filled in syringes (note: once when transferring to the hold tank and again at the fill machine).Endotoxin testing is performed on each batch.Fill room operators are trained and qualified on gowning for the fill room environment on an annual basis.Weekly bioburden testing on the components used to assemble the syringes.Continuous online monitoring of the wfi water quality (note: this is for toc and conductivity, not microbial requirements).Weekly bioburden and endotoxin testing of the usp purified water and wfi systems.Weekly endotoxin testing of the pure steam system.Each sterilizer is thoroughly validated before used for posiflush sterilization.Conclusion - bd was not able to duplicate or confirm the customer's indicated failure mode.All our monitoring testing and records from 2005 to date show no indication about suspected organisms.The product was within specifications.An absolute root cause for this incident cannot be determined.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, (b)(4).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.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.

Event Description

The following is the reported verbatim: "patient came to our outpatient area on (unknown date in 2015) for a blood transfusion.On (unknown date in 2015), patient came to our ed complaining of leg pain, probable cellulitis.Lactate of 11, repeat of 10.7.Positive blood cultures.Diagnosed with severe sepsis.Patient declined aggressive therapy due to underlying terminal illness, requested comfort measures only.Patient died on (unknown date in 2015), on (unknown date in 2015), blood cultures drawn.On day 1 of growth, shown to have gram negative rods.Patient expired later that day.On day 3 of growth, organism identified as non-fermenter species.Sent to mayo when two other patients had similar organisms in blood.Identified by them as elizabethkinga meningoseptica via mass spectrometry." concomitant medical products: on (b)(6) 2015 the patient also received furosemide 20 mg/ml via iv push, leukocyte reduced packed cells ab positive from two different donor units, and ns iv fluids.

• Brand Name: UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH
• Type of Device: FLUSH SYRINGE, SALINE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5541044
• MDR Text Key: 41649142
• Report Number: 2243072-2016-00005
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SEE H.
• 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
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 04/01/2016
• 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): Death