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)

Event Date 02/19/2018

Event Type  Death  

Manufacturer Narrative

There are multiple potential lot numbers provided for this incident.The information for each lot number is as follows: medical device lot #: 718711n: medical device expiration date: 7/5/2019, device manufacture date: 7/8/2017.Medical device lot #: 716192n: medical device expiration date: 6/9/2019, device manufacture date: 6/15/2017.Medical device lot #: 718611n: medical device expiration date: 7/4/2019, device manufacture date: 7/7/2017.Medical device lot #: 725181n, medical device expiration date: 9/7/2019, device manufacture date:9/12/2017.Medical device lot #: 725271n, medical device expiration date: 9/8/2019, device manufacture date: 9/12/2017.The initial reporter indicated that this incident occurred at (b)(6), associated with (b)(6) medical center in (b)(6).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 on (b)(6) 2018, a 5 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 100 usp units/ml was used on a patient's port.On (b)(6) 2018, the patient had symptoms that were not indicative of infection but blood cultures were drawn from the port.One of the 2 blood cultures turned positive for serratia marcescens.On (b)(6) 2018, the patient presented with sepsis.The patient had blood cultures drawn when they presented with sepsis on (b)(6) and those cultures were positive for serratia marcescens.On (b)(6) 2018, the patient died.The case is not yet linked to the cluster of serratia infections that are being investigated by cdc/fda.This is a new case in tn (not one the 4 cases that tn has reported to cdc) with a serratia bloodstream infection with a port and had received heparin among other medications.The pfge pattern for the serratia from this patient is not the same as the 11 cases under investigation with cdc/fda.

Manufacturer Narrative

Correction: type of report: the initial mdr was submitted as a 30-day report.Bd has changed our position on this incident and we are making a correction to report the mdr as a 5-day report.

Manufacturer Narrative

Investigation summary: lots: 718711n, 716192n, 718611n, 725181n, and 725271n.Prior to the report of infection evaluated in (b)(4), 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 (b)(4) was initiated to address this issue.There were no deviations, non-conformances, or out of specification conditions noted for the manufacture of possible lots 718711n, 716192n, 718611n, 725181n, and 725271n.Also finished goods sterility testing was sterile for all lots.100 % of retained samples for the lot numbers provided (120 units each) were visually inspected.No growth was seen (i.E., solution was clear).Forty (40) units of the retained samples were sent to (b)(4).For sterility testing in may 2018.The sterility testing was performed in an isolator per usp 71 membrane filtration method.Per the attached lab reports, after incubation, the retained samples exhibited no microbial growth.Investigation conclusion: the root cause analysis of the reported infection cases under capa (b)(4) has not identified a direct causation between the infections and bd franklin product.

Event Description

It was reported that on (b)(6) 2018, a 5 ml bd posiflush¿ heparin lock flush syringe, in 10 ml syringe, 100 usp units/ml was used on a patient's port.On (b)(6) 2018, the patient had symptoms that were not indicative of infection but blood cultures were drawn from the port.One of the 2 blood cultures turned positive for serratia marcescens.On (b)(6) 2018, the patient presented with sepsis.The patient had blood cultures drawn when they presented with sepsis on march 16 and those cultures were positive for serratia marcescens.On (b)(6) 2018, the patient died.The case is not yet linked to the cluster of serratia infections that are being investigated by cdc/fda.This is a new case in tn (not one the 4 cases that tn has reported to cdc) with a serratia bloodstream infection with a port and had received heparin among other medications.The pfge pattern for the serratia from this patient is not the same as the 11 cases under investigation with cdc/fda.

• 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: 7453058
• MDR Text Key: 106254907
• Report Number: 2134319-2018-00009
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 306513
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• 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