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 05/17/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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 Description

It was reported that a patient contracted an infection and had bloody returns while using an unspecified bd posiflush¿ heparin lock flush syringe from mid (b)(6) through the end of december.The patient received antibiotics on two separate occasions and had a visit to an emergency department.The patient's picc line site became red and swollen and the picc line was removed.The patient also received 10 days of antibiotics post picc line removal.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

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 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 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 (b)(4) product has not been identified.Investigation conclusion: unknown ¿ lot number was not provided.Prior to the report of infection evaluated in (b)(4), there was no trend for infection cases reported for (b)(4) product.This complaint is part of a new trend which began in april 2018.Capa (b)(4) was initiated to address this issue.As no lot number was provided, a dhr review could not be completed.Quantity of retained samples used for testing: 0 ¿ although retain samples are available for all lots manufactured in (b)(4), as the lot number was not provided, retain samples were not tested.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 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 (b)(4) 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: 7587547
• MDR Text Key: 110642899
• Report Number: 2134319-2018-00041
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• 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: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention