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
Health Effect - Clinical Codes	Abdominal Pain (1685); Unspecified Infection (1930); Discomfort (2330)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fda notified: the fda was made aware of this incident via voluntary medwatch mw5077333.This information was communicated to bd on 5/31/2018 by the fda.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using a 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe, a patient experienced pressure/pain across his stomach during insertion.The patient had an appointment with his physician the following day and was told he needed to have a procedure on his biliary opening.The biliary procedure was done on (b)(6) 2018.The patient also visited his oncologist and found that his white blood cell count was high and was prescribed antibiotics.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.
Event or Problem Description
It was reported that while using a 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe, a patient experienced pressure/pain across his stomach during insertion.The patient had an appointment with his physician the following day and was told he needed to have a procedure on his biliary opening.The biliary procedure was done on (b)(6) 2018.The patient also visited his oncologist and found that his white blood cell count was high and was prescribed antibiotics.*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.
Additional Manufacturer Narrative
Investigation summary: lot number 729311a for product code 306500 was provided for evaluation by our quality engineer team.Upon reviewing the production history for the provided lot number, no deviations or non-conformances were identified during the manufacturing process.A corrective and preventive action plan was initiated to further investigate and monitor this issue.One-hundred and twenty retained samples for the lot number provided were visually inspected and no abnormalities were observed in regards to the solution.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.Multiple samples produced before and after the provided lot number were sent for sterility testing and confirmed that no microbial growth was exhibited after incubation.This in combination with the daily environmental monitoring and sterility testing provides confidence in the sterility of the reported lot number.A direct causation between the reported infections and reactions and the bd franklin product has not been identified.Investigation conclusion: the root cause analysis of the reported infection/reaction causes under capa 350041 has not identified a direct causation between the infections/reactions and the bd franklin product.

• 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: 7571048
• Report Number: 2134319-2018-00066
• Device Sequence Number: 16568654
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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 Expiration Date: 10/19/2020
• Device Catalogue Number: 306500
• Device Lot Number: 729311A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/19/2018
• 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: Required Intervention