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

Catalog Number UNKNOWN

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

Patient Problem Bacterial Infection (1735)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Fda notified?: the fda was made aware of this incident via voluntary medwatch 5077227.This information was communicated to bd on 5/29/2018 by the fda.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that a patient contracted a serratia marcescens infection that developed in her indwelling port that had been placed for chemotherapy and was hospitalized twice.The patient was treated for the infection.An unspecified bd posiflush¿ heparin lock flush 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.

Event Description

It was reported that a patient contacted a serratia marcescens infection that developed in her indwelling port that had been placed for chemotherapy and was hospitalized twice.The patient was treated for the infection.An unspecified bd posiflush¿ heparin lock flush 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

Investigation summary: prior to the report of infection evaluated in (b)(4), there was no trend for infection or reaction cases reported for franklin product.The complaint is part of a new trend which began in april 2018.As no lot number was provided, a dhr review could not be completed.Samples and/or pictures were not provided for evaluation.A review of all lot sterility testing performed for product released between april 2015 & may 2018 confirmed that no organism growth was identified for any lots released during the self life of this product.Investigation conclusion: 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: UNSPECIFIED BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE
• Type of Device: PREFILLED HEPARIN FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7594813
• MDR Text Key: 110893138
• Report Number: 2134319-2018-00065
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention