MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE; PREFILLED SALINE FLUSH SYRINGE

Catalog Number UNKNOWN

Device Problem Nonstandard Device (1420)

Patient Problem Unspecified Infection (1930)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that a patient contracted an infection.It is unknown if any medical interventions were provided and no further details were provided.The patient associated the use of an unspecified bd posiflush¿ normal saline syringe with this incident.*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

Additional information: medical device lot #: 732911c medical device expiration date: 11/24/2020.Device manufacture date: 11/28/2017.The patient gave the following response to a request for more information.Response to third info request stated, " ¿ what was the date(s) that the symptoms began? sometime after (b)(6) 2018.¿ was the syringe being used during home care or while in a facility/outpatient setting? used for in-home care ¿ what was the syringe being used for? for flushing, through a tube inserted through my lower flanks into my kidneys.¿ were any cultures taken to test for infection? yes.¿ if yes, were any tests positive and what was it positive for? yes.The tests were positive for urinary tract infections (utis).¿ what was the culture source (i.E.Blood, port, etc.)? urine ¿ what medical intervention was taken to address the infection? antibiotics, the doctors advise me to immediately stop using your flush syringes ¿ are you able to provide the part and/or lot number of the syringe(s)? yes.Ndc: 08290-3065-00 lot: 732911c ¿ are any samples of the same lot number available to be returned for investigation? yes.For investigation purposes, i already provided the lot number of the 982 pieces used.¿ please provide any additional information you may consider important to help aid in the investigation.My doctors prescribed 1000 pieces of bd pre-filled normal saline 0.9% flush inj, 10ml syringes for treatment as already stated above.I went to walgreens (my pharmacy) to collect the pre-filled syringes.Three (3) times a day, and per the doctors and pharmacy¿s direction, i flushed through tubes sticking out from my kidneys, which goes into my kidneys, and down through my ureters and into my bladder.On the (b)(6) 2018, i received a letter from walgreens to the effect that the syringes received are being recalled due to potential contamination with serratia marcescens bacterium.I was to check my remaining syringes and call your company if some selected numbers in the letter sent to me march the lot number of my syringes.Unfortunately, my syringes matched a selected lot number, which means my syringes were affected.I had already used 982 out of the 1000 pieces.I called your company on the (b)(6) 2018 and spoke to one (b)(6) at the company.

Event Description

It was reported that a patient contracted an infection.It is unknown if any medical interventions were provided and no further details were provided.The patient associated the use of an unspecified bd posiflush¿ normal saline syringe with this incident.*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 contracted an infection.It is unknown if any medical interventions were provided and no further details were provided.The patient associated the use of an unspecified bd posiflush¿ normal saline syringe with this incident.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 emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: b.2.Event attributed to: other.D.8.Device single use?: no.H.3.Device returned to manufacture: no.Investigation summary: lot number 732911c for product code 306500 was provided for evaluation by our quality engineer team.Upon reviewing the production history for the provided lot number, 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 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 (b)(4) product has not been identified.Prior to the report of infection evaluated in mp-18-1248-sa, there was no trend for infection cases reported for (b)(4) product.This complaint is part of a new trend which began in april 2018.Capa 350041 was initiated to address this issue.100% of retained samples for lot (120 units) were visually inspected.No growth was seen (i.E., solution was clear).Lot 732911c was manufactured between lots 731012n and 735311n, 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.A review of the dhr and supporting documentation for lot 732911c was performed.There were no deviations or non-conformances or out of specifications related to the manufacture of lot 732911c or the raw materials used to manufacture this lot.The root cause analysis of the reported infection cases under capa 350041 has not identified a direct causation between the infections and the bd (b)(4) product.

• Brand Name: UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: PREFILLED SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7799643
• MDR Text Key: 117694557
• Report Number: 2134319-2018-00110
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other