• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Vomiting (2144); Reaction (2414); Test Result (2695)
Event Date 09/15/2015
Event Type  Injury  
Manufacturer Narrative
(b)(6). The medwatch was received with four potential devices used in this incident. Catalog 3645234 has been identified as a nephron pharmaceuticals device. Catalog 409488820 has been identified as a hospira device. The following catalog numbers reflect bd devices: (b)(4), 10 ml fill in 10 ml diameter bd posiflush normal saline filled syringe, 510(k)# k003553. (b)(4), 10 ml fill in 10 ml bd pre-filled normal saline filled flush syringe, 510(k)# k011982. As they are manufactured at 2 different locations, and the exact device used in this incident is unknown, bd headquarters (b)(4) has been used as the manufacturing location. The medical device expiration dates are unknown as the lot numbers are unknown. This incident was notified from the fda, ref mw5059286. 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: 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. Conclusion- bd was not able to duplicate or confirm the customer's indicated failure mode. One bd investigator also noted the following: from a (b)(6) search on non-fermenting, 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 (b)(6) 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 (b)(6) 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. ".
Event Description
It was reported that the patient was seen in interventional radiology for a steroid injection of the lumbar spine. The patient then returned to the emergency department complaining of nausea and vomiting. The patient was found to have positive blood cultures. The patient was discharged to home on cipro. The lab at the reporter facility labeled the organism as non-fermenter species, resistant to several antibiotics but sensitive to cipro. After two other patient were found to have non-fermenter species in blood cultures, specimens were sent to an unspecified lab where they were id'd as (unspecified) by mass spectrometry. Repeat blood cultures for this patient were negative. The reasons for use of the device was reported as iv start and iv flush. Concomitant medical products were reported as bupivicaine mf 0. 25% in a 30 ml vial subcutaneous, triacinolone 2ml (40mg/ml) spinal injection, combined with 1% lidocaine 2ml (10mg/ml), one vial of omipaque mixed with 0. 9% ns, 8. 4% sodium bicarbonate inj, 50meq. No further information is available as no reporter contact information was provided.
Manufacturer Narrative
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 the posiflush sp history 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. 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. Based on the investigation results to date, an absolute root cause for this incident cannot be determined. From a (b)(6) search on non-fermenting and elizabethkingia meningoseptica the following indicates these are basic organisms that can be acquired in a hospital setting. 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. (b)(4). 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.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
MDR Report Key5481323
MDR Text Key39745983
Report Number2243072-2016-00002
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2016
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

Patient Treatment Data
Date Received: 03/04/2016 Patient Sequence Number: 1