MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; PREFILLED SALINE FLUSH SYRINGE

Catalog Number 306546

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303)

Patient Problem Septic Shock (2068)

Event Date 04/01/2018

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 customer was diagnosed with sepsis three times and went into septic shock.The patient fell ill on (b)(6) 2018 was admitted into icu on (b)(6) 2018 for five days.Infection was cleared each time and line was replaced.Blood cultures tested positive for serratia marcesens for the third time within two months since (b)(6) 2018.The patient associated a 10 ml bd posiflush¿ normal saline syringe, in 10 ml 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(b)(4) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the (b)(4) identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.(b)(4)¿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, (b)(4).

Manufacturer Narrative

Investigation summary: no samples were provided for evaluation.There was no documentation of issues for the complaint of this batch # during this production run.All our inspections performed while manufacturing this batch # was accepted; no rejections were documented.Controls in place at the manufacturing site: bioburden tested on a weekly basis.An overkill sterilization process is used.Environmental testing within the filling area is done on a biweekly basis.The sterilization process is challenged and re-qualified annually.The solution is filtered twice before it is filled in syringes (note: once when transferring to the hold tank and again at the fill machine).Endotoxin testing is performed on each batch.Fill room operators are trained and qualified on gowning for the fill room environment on an annual basis.Weekly bioburden testing on the components used to assemble the syringes.Continuous online monitoring of the wfi (water for injection) water quality (note: this is for toc (total organic carbon) and conductivity, not microbial - weekly bioburden and endotoxin testing of the usp (united states pharmacopeia) purified water and wfi systems.Weekly endotoxin testing of the pure steam system.Each sterilizer is thoroughly validated before use for posiflush sterilization.A three year review of complaints, environmental monitoring results, water testing results, and quality notifications have confirmed that the serratia marcescens organism has not been recovered in the (b)(4) plant.In addition, the posiflush product produced within (b)(4) is terminally sterilized through steam sterilization which is requalified annually.Furthermore, there is no morphological evidence of serratia marcescens ability to survive the steam conditions1 used to sterilize the posiflush product manufactured in the (b)(4) plants.For validation, bd (b)(4) & bd (b)(4) uses the spore forming, rod-shaped, gram-positive, thermophile geobacillus stearothermophillus as our biological indicator, along with bacillus atrophaeus.The formation of endospores has not been reported in any species of serratia, thus its resistance to steam sterilization is scientifically remote, further it is a motile organism with growing temperatures ranging from 5¿40 °c, which is well below our >121 °c processing temperatures.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.A device history review was completed and there was no documentation of issues for the complaint of batch # 8017654 during their production run.There were no qns issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.Investigation conclusion: root cause could not be determined.There were no qns issued during the production of this batch listed in the complaint.All inspections and testing were accepted during the production of this batch.

Event Description

It was reported that a customer was diagnosed with sepsis three times and went into septic shock.The patient fell ill on (b)(6) 2018 was admitted into icu on (b)(6) 2018 for five days.Infection was cleared each time and line was replaced.Blood cultures tested positive for serratia marcesens for the third time within two months since (b)(6) 2018.The patient associated a 10 ml bd posiflush¿ normal saline syringe, in 10 ml 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 customer was diagnosed with sepsis three times and went into septic shock.The patient fell ill on (b)(6) 2018 was admitted into icu on (b)(6) 2018 for five days.Infection was cleared each time and line was replaced.Blood cultures tested positive for serratia marcesens for the third time within two months since (b)(6) 2018.The patient associated a 10 ml bd posiflush¿ normal saline syringe, in 10 ml 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: sex: female.Event attributed to: hospitalization.Device single use?: no.Device returned to manufacture: no.

Event Description

It was reported that a customer was diagnosed with sepsis three times and went into septic shock.The patient fell ill on (b)(6) 2018 was admitted into icu on (b)(6) 2018 for five days.Infection was cleared each time and line was replaced.Blood cultures tested positive for serratia marcesens for the third time within two months since (b)(6) 2018.The patient associated a 10 ml bd posiflush¿ normal saline syringe, in 10 ml 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: seven additional lot numbers were provided.The information for each lot number is as follows: medical device lot #: 8017672, medical device expiration date: 12/31/202 and device manufacture date: 1/17/2017.Medical device lot #: 7292773, medical device expiration date: 10/31/2020 and device manufacture date: 10/19/2017.Medical device lot #: 8017592, medical device expiration date: 12/31/2020 and device manufacture date: 1/17/2017.Medical device lot #: 7319511, medical device expiration date: 11/30/2020 and device manufacture date: 11/15/2017.Medical device lot #: 7319545, medical device expiration date: 10/31/2020 and device manufacture date: 11/15/2017.Medical device lot #: 7268679, medical device expiration date: 8/31/2020 and device manufacture date: 9/25/2017.Medical device lot #: 7333627, medical device expiration date: 11/30/2020 and device manufacture date: 11/29/2017.Updated investigation: the following lot numbers were also included with this complaint: 8017672, 7292773, 8017592, 7319511, 7319545, 7268679, and 7333627.There was no documentation of issues for the complaint of all these batch numbers during their production run.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
• Type of Device: PREFILLED SALINE FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7684413
• MDR Text Key: 113870347
• Report Number: 1911916-2018-00382
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8017654
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention