MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 5ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 10ML SYRINGE, 100 USP UNITS/ML; PREFILLED HEPARIN FLUSH SYRINGE

Catalog Number 306513

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Death (1802); Diarrhea (1811); Nausea (1970); Constipation (3274)

Event Date 06/25/2018

Event Type  Death  

Manufacturer Narrative

Fda notified?: the fda was made aware of this incident via voluntary medwatch 5077796.This information was communicated to bd on 6/25/2018 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 Description

It was reported that after a patient used a 5 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 100 usp units/ml, she had symptoms of diarrhea, constipation and nausea.The patient was evaluated by a doctor, diagnosed with a blood infection, and given antibiotics.The patient also had bacteria in her urine.The patient ultimately passed away.*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

This supplemental emdr is filed to provide the following omitted fields: sex: female.Event attributed to: death.Device single use?: no.Device returned to manufacture: no.Investigation summary: lot number 726111n for product code 306513 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 may 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 infection and death and the bd (b)(4) product has not been identified.Prior to the report of infection evaluated in (b)(4), there was no trend for reaction/infection cases reported for (b)(4) product.This complaint is part of a new trend which began in (b)(6) 2018.Capa (b)(4) was initiated to address this issue.There were no deviations, non-conformances, or out of specification conditions noted during the manufacture of lot 726111n.100% of retained samples for the lot (120 units) were visually inspected.No growth was seen (i.E., the solution was clear).Lot 726111n was manufactured between lots 725591n and 726211n, 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 & 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.

Event Description

It was reported that after a patient used a 5 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 100 usp units/ml, she had symptoms of diarrhea, constipation and nausea.The patient was evaluated by a doctor, diagnosed with a blood infection, and given antibiotics.The patient also had bacteria in her urine.The patient ultimately passed away.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, 100 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: 7698490
• MDR Text Key: 114323473
• Report Number: 2134319-2018-00089
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065135
• UDI-Public: 30382903065135
• 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
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/17/2019
• Device Catalogue Number: 306513
• Device Lot Number: 726111N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death