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 Problem Microbial Contamination of Device (2303)

Patient Problem Bacterial Infection (1735)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Eight lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 711471n; medical device expiration date: 10/23/2018; device manufacture date: 4/26/2017.Medical device lot #: 714291n; medical device expiration date: 11/21/2018 ; device manufacture date: 5/26/2017.Medical device lot #: 717893n; medical device expiration date: 12/26/2018; device manufacture date: 6/30/2017.Medical device lot #: 718991n; medical device expiration date: 1/7/2019; device manufacture date: 7/13/2017.Medical device lot #: 720911n; medical device expiration date: 1/27/2019; device manufacture date: 7/31/2017.Medical device lot #: 725091n; medical device expiration date: 3/6/2019; device manufacture date: 9/11/2017.Medical device lot #: 726591n; medical device expiration date: 3/21/2019; device manufacture date: 9/27/2017.Medical device lot #: 727712n; medical device expiration date: 4/3/2019; device manufacture date: 10/6/2017.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 the (b)(6) confirmed a case of serratia marcescens bloodstream infection from (b)(6) with pfge patterns indistinguishable from the original co outbreak pattern.The patient is a (b)(6) year old male diagnosed with lymphoma and is immunocompromised with an implanted port that was accessed in an outpatient infusion clinic.The patient presented to a hospital with positive serratia marcescens culture on (b)(6) 2018, was treated, and subsequently discharged.The specific treatment provided is unknown.The device implicated with this incident is a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 10 usp units/ml.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)¿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)(6).

Event Description

It was reported that the cdc confirmed a case of serratia marcescens bloodstream infection from massachusetts with pfge patterns indistinguishable from the original co outbreak pattern.The patient is a 34 year old male diagnosed with lymphoma and is immunocompromised with an implanted port that was accessed in an outpatient infusion clinic.The patient presented to a hospital with positive serratia marcescens culture on (b)(6) 2018, was treated, and subsequently discharged.The specific treatment provided is unknown.The device implicated with this incident is a 5ml bd posiflush¿ heparin lock flush syringe, in 10ml syringe, 10 usp units/ml.*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

Lot numbers 714291n, 711471n, 726591n, 718991n, 717893n, 725091n, 720911n, and 727712n for product code 306510 were provided for evaluation by our quality engineer team.Upon reviewing the production history for the provided lot numbers, no deviations or non-conformances were identified during the manufacturing process.Prior to the report of infection evaluated in mps-18-1248-sa, there was no trend for infection cases reported for franklin product.The complaint is part of a new trend which began in april 2018.Capa 350041 was initiated to address this issue.Lot: 714291n, 711471n, 726591n, 718991n, 717893n, 725091n, 720911n, 727712n there were no deviations, non-conformances, or out of specifications conditions noted during the manufacture of the reported lots.120 retained samples of each lot were visually inspected, no growth was seen (i.E., solution was clear).Lot 727712n was manufactured between lots 726971n and 731012n, both of which exhibited no growth during the confirmatory sterility testing.Lot 720911n was manufactured between lots 719291n and 721481n, both of which exhibited no growth during the confirmatory sterility testing.Lot 725091n was manufactured between lots 724291n and 725181n, both of which exhibited no growth during the confirmatory sterility testing.Lot 717893n was manufactured between lots 716192n and 718091n, both of which exhibited no growth during the confirmatory sterility testing.Lot 714291n was manufactured between lots 705311b and 716192n, both of which exhibited no growth during the confirmatory sterility testing.Lot 711471n was manufactured between lots 705311b and 716192n, both of which exhibited no growth during the confirmatory sterility testing.Lot 726591n was manufactured between lots 726571n and 726851n, both of which exhibited no growth during the confirmatory sterility testing.Lot 718991n was manufactured between lots 718711n and 719291n, 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 lots release, provides confidence in the sterility of the complaint lots.A review of all 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 corrective and preventive action plan was initiated to further investigate and monitor this issue.One-hundred and twenty retained samples for each lot number provided were visually inspected and no abnormalities were observed in regards to the solution.This in combination with the daily environmental monitoring and sterility testing provides confidence in the sterility of the reported lot numbers.The root cause analysis of the reported infection cases under capa 350041 has not identified a direct causation between the infections and the bd franklin product.

• 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
• MDR Report Key: 7541269
• MDR Text Key: 109353706
• Report Number: 2134319-2018-00025
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065104
• UDI-Public: 30382903065104
• Combination Product (y/n): N
• PMA/PMN Number: K011967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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: SEE H.10.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 34 YR