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	306518
Health Effect - Clinical Codes	Death (1802); Sepsis (2067)
Date of Event	01/10/2018
Type of Reportable Event	Death
Additional 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 or Problem Description
It was reported that a patient had surgery for an abscess on (b)(6) 2018.While hospitalized, the patient was treated with 10 ml bd¿ pre-filled normal saline syringes, in 10 ml syringe with bd¿ blunt plastic cannula.The patient was released and prescribed 10 ml bd¿ pre-filled normal saline syringes, in 10 ml syringe with bd¿ blunt plastic cannula as well.The patient also had several blood and other tests at the hospital.Ultimately, the patient expired from sepsis on (b)(6) 2018.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 (b)(4) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and (b)(4) 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, fda, and (b)(4).
Additional Manufacturer Narrative
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 regarding the bd (b)(4) products.Upon the increase of infection reports beginning in april 2018, a corrective and preventive action plan (capa (b)(4)) 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 infections and the bd franklin product has not been identified.

• Brand Name: 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
• Common Device Name: PREFILLED SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7571837
• Report Number: 2134319-2018-00046
• Device Sequence Number: 11118884
• Product Code: FOZ
• UDI-Device Identifier: 30382903065180
• UDI-Public: 30382903065180
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K011982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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
• Operator of Device: Other
• Device Catalogue Number: 306518
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death