MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE

Catalog Number 306500

Device Problem Nonstandard Device (1420)

Patient Problem Death (1802)

Event Date 07/19/2018

Event Type  Death  

Manufacturer Narrative

Date of death: unknown.The date received by manufacturer has been used for this field.Date of event: unknown.The date received by manufacturer has been used for this field.Two lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 720512a.Medical device expiration date: 7/23/2020.Device manufacture date: 7/26/2017.Medical device lot #: 710212c.Medical device expiration date: 4/11/2020.Device manufacture date: 4/17/2017.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

A patient death was reported.The wife of the patient indicated that 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringes were used for a year before the patient passed away.When the patient's wife received the recall notice she reported the incident.She did not indicate if the patient was hospitalized or if he died from an infection but that she was concerned after receiving the recall notice.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

Correction: due to an it issue beginning on 7/3/2018, previously filed emdr's did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: male; event attributed to: death; device single use?: no; device returned to manufacture: yes.Investigation summary: lot numbers 710212c and 720512a for product code 306500 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.A corrective and preventive action plan was initiated to further investigate and monitor this issue.One-hundred and twenty retained samples for each of the lot numbers provided were visually inspected and no abnormalities were observed in regards to the solution.Five physical samples from lot number 710212c were provided for evaluation of this incident.A visual inspection of the returned samples did not reveal any defects or abnormalities.As the shipping and storage conditions of the returned samples were unknown, further analysis could not be performed.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 numbers 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 numbers.A direct causation between the reported 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 infection cases reported for (b)(4) product.Infection and related cases 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 related to the manufacture of lots 710212c and 720512a.5 physical samples were returned on (b)(6) 2018 240 retained samples (120 of each lot) were visually inspected for growth.No growth was seen (i.E., the solution was clear).The five syringe samples from lot number 710212c, provided by the customer were visually inspected.No defects were observed.It is unknown as to the shipping or storage conditions of the sample syringes therefore further testing could not be performed.Lot number 710212c was manufactured between lots 705311b and 716192n, both of which exhibited no growth during the confirmatory sterility testing.Lot 720512a was manufactured between tested lots 719291n and 721481n.This in combination with the daily environmental monitoring and original sterility testing for the lot releases, provides confidence in the sterility of the complaint lots.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 (b)(4) has not identified a direct causation between the infections and the bd (b)(4) product.

Event Description

A patient death was reported.The wife of the patient indicated that 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringes were used for a year before the patient passed away.When the patient's wife received the recall notice she reported the incident.She did not indicate if the patient was hospitalized or if he died from an infection but that she was concerned after receiving the recall notice.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: 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
• Type of Device: PREFILLED SALINE 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: 7772406
• MDR Text Key: 116742194
• Report Number: 2134319-2018-00111
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065005
• UDI-Public: 30382903065005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

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: 306500
• Device Lot Number: SEE H.10.
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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