MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE; PREFILLED SALINE FLUSH SYRINGE

Catalog Number UNKNOWN

Device Problem Nonstandard Device (1420)

Patient Problems Death (1802); Fever (1858); Unspecified Infection (1930); Pulmonary Edema (2020)

Event Date 04/25/2018

Event Type  Death  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that a patient had visited multiple hospitals from (b)(6) 2018 - (b)(6) 2018 for blood in stool, leaking heart valve, and fluid in his lungs.The patient received a picc line for antibiotics and an unspecified bd posiflush¿ normal saline syringe was used each day for one week.Cultures were taken and tested positive, but it is not known what the test results showed or what the source of the culture was.The patient was seen by his infectious disease doctor in which it was stated that the patient¿s heart valves were fine, but a week later patient was running a slight fever and sounded as if fluid was in his lungs per the home nurse.The patient saw infectious disease doctor again who had patient transferred to emergency department and was told that his valves were compromised and would need to be replaced.The patient passed away one week later.The spouse of patient stated that cause of death is listed on the death certificate and did not state what the cause of death was.Out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium.Bd was notified by the u.S.Food and drug administration (fda) and centers for disease control and prevention (cdc) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and cdc identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.Cdc¿s initial investigation found that affected patients had received treatment using certain bd flush products.To date, there is no evidence of bd flush product testing positive for this bacterium.Investigations are ongoing by bd, fda, and cdc.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: male, event attributed to: death, device single use?: no, device returned to manufacture: no.Investigation summary: as both a lot number and sample were unavailable for this incident, a full investigation consisting of a sample analysis and a device history record review could not be completed.Prior to april 2018, there was no trend for infection or reaction regarding the bd franklin products.Upon the increase of infection and reaction reports beginning in april 2018, a corrective and preventive action plan was initiated to address the issue.A review of all lot sterility testing performed for product released between april 2015 and may 2018 confirmed that no organism growth was identified for any lots released during the shelf life of this product.A direct causation between the reported death and the bd franklin product has not been identified.Prior to the report of infection evaluated in (b)(4), there was no trend for infection cases reported for franklin product.This complaint is part of a new trend which began in april 2018.Capa (b)(4) was initiated to address this issue.As no lot number was provided, a dhr review could not be completed.No samples or pictures provided.A review of all lot sterility testing performed for product released between april 2015 and may 2018 confirmed that no organism growth was identified for any lots released during the shelf life of this product.The root cause analysis of the reported infection cases under capa (b)(4) has not identified a direct causation between the infections and bd franklin product.

Event Description

It was reported that a patient had visited multiple hospitals from (b)(6) 2018 - (b)(6) 2018 for blood in stool, leaking heart valve, and fluid in his lungs.The patient received a picc line for antibiotics and an unspecified bd posiflush¿ normal saline syringe was used each day for one week.Cultures were taken and tested positive, but it is not known what the test results showed or what the source of the culture was.The patient was seen by his infectious disease doctor in which it was stated that the patient¿s heart valves were fine, but a week later patient was running a slight fever and sounded as if fluid was in his lungs per the home nurse.The patient saw infectious disease doctor again who had patient transferred to emergency department and was told that his valves were compromised and would need to be replaced.The patient passed away one week later.The spouse of patient stated that cause of death is listed on the death certificate and did not state what the cause of death was.*out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium.Bd was notified by the u.S.Food and drug administration (fda) and centers for disease control and prevention (cdc) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and cdc identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.Cdc¿s initial investigation found that affected patients had received treatment using certain bd flush products.To date, there is no evidence of bd flush product testing positive for this bacterium.Investigations are ongoing by bd, fda, and cdc.

• Brand Name: UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: PREFILLED SALINE FLUSH SYRINGE
• 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: 7672138
• MDR Text Key: 113514563
• Report Number: 2134319-2018-00087
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death