MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 5 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE

Catalog Number 306502

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the (b)(4) confirmed a case of serratia marcescens bloodstream infection from (b)(6) with pfge patterns indistinguishable from the original co outbreak pattern.The patient is a (b)(6) year old male diagnosed with lymphoma and is immunocompromised with an implanted port that was accessed in an outpatient infusion clinic.The patient presented to a hospital with positive serratia marcescens culture on (b)(6) 2018, was treated, and subsequently discharged.The specific treatment provided is unknown.The device implicated with this incident is a 5 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe.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).

Manufacturer Narrative

Lot number 725511a for product code 306502 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.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 april 2018.Capa 350041was initiated to address this issue.There were no deviations, non-conformances, or out of specification conditions noted during the manufacture of lot 725511a 100% of retained samples for the lot (120 units) were visually inspected.No growth was seen (i.E., solution was clear).Lot number 725511a was manufactured between lots 725271n and 725591n, 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 release, provides confidence in the sterility of the complaint lot.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.The root cause analysis of the reported infection cases under capa 350041 has not identified a direct causation between the infections and the bd franklin product.

Event Description

It was reported that the cdc confirmed a case of serratia marcescens bloodstream infection from massachusetts with pfge patterns indistinguishable from the original co outbreak pattern.The patient is a 34 year old male diagnosed with lymphoma and is immunocompromised with an implanted port that was accessed in an outpatient infusion clinic.The patient presented to a hospital with positive serratia marcescens culture on (b)(6) 2018, was treated, and subsequently discharged.The specific treatment provided is unknown.The device implicated with this incident is a 5 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe *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: 5 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: 7541305
• MDR Text Key: 109222019
• Report Number: 2134319-2018-00039
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065029
• UDI-Public: 30382903065029
• Combination Product (y/n): N
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/11/2020
• Device Catalogue Number: 306502
• Device Lot Number: 725511A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR