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

Catalog Number 306500

Device Problem Nonstandard Device (1420)

Patient Problems Unspecified Infection (1930); Pneumonia (2011); Urinary Tract Infection (2120)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.

Event Description

It was reported that a patient was diagnosed in (b)(6) 2017 with a urinary tract infection, pneumonia, a blood infection and that the, "lining of his chest was infected." it is unknown if the patient received any medical interventions.A 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe was associated with this incident.*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 (b)(4) 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.(b)(4)¿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, (b)(4).

Event Description

It was reported that a patient was diagnosed in november 2017 with a urinary tract infection, pneumonia, a blood infection and that the, "lining of his chest was infected." it is unknown if the patient received any medical interventions.A 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe was associated with this incident.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

Additional information: on 1/23/2019, new information from the initial reporter was received that contained a previously unknown lot # for this incident.An additional investigation was also conducted against the provided lot number.The information is as follows: d.4.Medical device lot #: 732511a d.4.Medical device expiration date: 11/20/2020 h.4.Device manufacture date: 11/27/2017 h.10.Investigation summary: dhr: there were no deviations, non-conformances or out of specification conditions related to the manufacture of lot 732511a or the raw materials used to manufacture the lot.100% of retained samples for the lot (120 units) were visually inspected.No growth was seen (i.E., the solution was clear).Lot number 732511a was manufactured between lots 731012n and 735311n, both of which exhibited no growth during the confirmatory sterility testing.This, in combination with the daily environmental monitoring and original sterility testing for the lot provides confidence in the sterility of the complaint lot.There was no defect identified in the photos provided.H3 other text : see h.10.

Event Description

"it was reported that a patient was diagnosed in november 2017 with a urinary tract infection, pneumonia, a blood infection and that the, ""lining of his chest was infected."" it is unknown if the patient received any medical interventions.A 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe was associated with this incident.*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: a.3.Sex: male.B.2.Event attributed to: other.D.8.Device single use?: no.H.3.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 (b)(6) 2018, there was no trend for infection regarding the bd franklin products.Upon the increase of infection reports beginning in (b)(6) 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 june 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 infections and the bd franklin product has not been identified.Prior to the report of infection evaluated in mps-18-1248-sa, there was no trend for infection cases reported for franklin product.This complaint is part of a new trend which began in (b)(6) 2018.Capa (b)(4) was initiated to address this issue.As no lot number was provided, a dhr review could not be performed.Samples and/or pictures were not provided for evaluation.A review of all lot sterility testing performed for product released between april 2015 & june 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 the bd franklin product.

• Brand Name: 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
• Type of Device: PREFILLED SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7795360
• MDR Text Key: 117567413
• Report Number: 2134319-2018-00107
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• Combination Product (y/n): N
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/20/2020
• Device Catalogue Number: 306500
• Device Lot Number: 732511A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other