MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML; PREFILLED HEPARIN FLUSH SYRINGE

Catalog Number 306510

Device Problems Contamination (1120); Nonstandard Device (1420)

Patient Problem Bacterial Infection (1735)

Event Date 04/12/2018

Event Type  Death  

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 a (b)(6) year old patient with a tunneled line who had been diagnosed with heart failure, tested positive for serratia on (b)(6) 2018 and passed away.The patient's discharge summary states that patient's major medical illness was non ischemic cardiomyopathy, mixed septic, cardiogenic shock, hypoxemic respiratory failure, and v-tach arrest.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 (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.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, (b)(4).

Manufacturer Narrative

Additional information: on 7/12/2018, the user facility provided a catalog number for this incident.The updated information is as follows: medical device brand name: 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 10 usp units/ml.Medical device catalog #: 306510.Unique identifier (udi) #: (b)(4).Pma / 510(k)#: k011967.

Event Description

It was reported that a (b)(6) year old patient with a tunneled line who had been diagnosed with heart failure, tested positive for serratia on (b)(6) 2018 and passed away.The patient's discharge summary states that patient's major medical illness was non ischemic cardiomyopathy, mixed septic & cardiogenic shock, hypoxemic respiratory failure, and v-tach arrest.A 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 10 usp units/ml 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 (b)(4) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the (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, (b)(4).

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: death.Device single use? no.Device returned to manufacturer: no.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 (b)(6) 2018, there was no trend for infection regarding the bd franklin products.Upon the increase of infection reports beginning in (b)(6) 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 june 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 infection and death and the bd franklin product has not been identified.

Event Description

"it was reported that a (b)(6) patient with a tunneled line who had been diagnosed with heart failure, tested positive for serratia on (b)(6) 2018 and passed away.The patient's discharge summary states that patient's major medical illness was non ischemic cardiomyopathy, mixed septic & cardiogenic shock, hypoxemic respiratory failure, and v-tach arrest.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.".

• Brand Name: 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 10 USP UNITS/ML
• Type of Device: PREFILLED HEPARIN FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7684421
• MDR Text Key: 113863845
• Report Number: 2134319-2018-00099
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2018

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
• Device Operator: Other
• Device Catalogue Number: 306510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 06/18/2018; 06/18/2018
• Supplement Dates FDA Received: 07/17/2018; 09/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 35 YR