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

Patient Problems Bacterial Infection (1735); Fatigue (1849); Fever (1858); Pain (1994); Weakness (2145)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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 patient contracted an infection and had fever, fatigue, pallor, pain and weakness while using a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 100 usp units/ml at home on her picc line.Two initial sets of cultures were taken and on (b)(6) 2018 were positive for staphylococcus epidermidis.The source was reported to be the patient's picc line but it was not changed.The patient was hospitalized and was treated with iv vancomycin for seven days.The patient was discharged to home and received iv daptomycin for an additional 10 days.As of (b)(6) 2018, the patient indicated that she was still using iv vancomycin and heparin locks through her picc line and anticipated using them for at least another week.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)(6) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and (b)(6) identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.(b)(6) 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)(6).

Event Description

It was reported that a patient contracted an infection and had fever, fatigue, pallor, pain and weakness while using a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 100 usp units/ml at home on her picc line.Two initial sets of cultures were taken and on (b)(6) 2018 were positive for staphylococus epidermidis.The source was reported to be the patient's picc line but it was not changed.The patient was hospitalized and was treated with iv vancomycin for seven days.The patient was discharged to home and received iv daptomycin for an additional 10 days.As of on (b)(6) 2018, the patient indicated that she was still using iv vancomcin and heparin locks through her picc line and anticipated using them for at least another week.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: lot number: 724472n for product code: 306513 was provided for evaluation by our quality engineer team.A device history record review revealed one environmental action level reached during the manufacturing process for the provided lot number.The organism identified from the action level reached was not related to the recall.There were no indications that the action level reached affected the finished product, and the sterility tests for the lot number tested as sterile prior to release.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.A direct causation between the reported infections and the bd franklin product has not been identified.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 350041 was initiated to address this issue.A review of the device history record and the supporting documentation for lot: 724472n was performed.A viable environmental action level as reached during the manufacture of lot: 724472n.The organism identified form the action level reached was not the serrati marcescens organism related to the recall.There were no indications that the action level reached may have affected the finished product.The sterility test result for lot: 724472n was tested as "sterile." there were no other non-conformances, deviations or out of specification conditions noted during the manufacture of lot: 724472n.100% of retained samples for the lot: (b)(4)units) were visually inspected.No growth was seen (i.E., solution was clear).After incubation, the retained samples from all of the tested lots exhibited no microbial growth.Lot: 724472n was manufactured between lots: 724291n and 725181n, 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 & 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 no identified as direct causation between the infections and the bd franklin product.

• 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
• MDR Report Key: 7550772
• MDR Text Key: 109488973
• Report Number: 2134319-2018-00035
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065135
• UDI-Public: 30382903065135
• Combination Product (y/n): N
• PMA/PMN Number: K011967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

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 Expiration Date: 08/31/2019
• Device Catalogue Number: 306513
• Device Lot Number: 724472N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention