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 Problem Complaint, Ill-Defined (2331)

Event Date 06/05/2018

Event Type  Injury  

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 patient felt ill after using a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 100 usp units/ml.The patient indicated that she would contact her doctor and get a blood test.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 felt ill after using a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 100 usp units/ml.The patient indicated that she would contact her doctor and get a blood test.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 mps-18-1248-sa, there were no trends for infection/reaction 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.The dhr review found one non-conformance issued for an environmental action level reached.The action level was reached within a flow hood in clean room c; the organism was not identified as serratia (refer to mps-18-1248-sa).This is an isolated occurrence with no indication that the action level reached may have affected product manufactured in that room.Sterility testing performed for lot: 724472n confirmed no organism growth.100% of retained samples for the lot (b)(4) units) were visually inspected.No growth was seen (i.E., the solution was clear).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.Investigation conclusion: the root cause analysis of the reported infection/reaction cases under capa: 350041 has not identified a direct causation between the infections/reactions and the bd franklin product.Capa: 350041 has been initiated for this issue.

• 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: 7639898
• MDR Text Key: 112420268
• Report Number: 2134319-2018-00074
• 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: 09/11/2018

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: 08/03/2019
• Device Catalogue Number: 306513
• Device Lot Number: 724472N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention