MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9129750, medical device expiration date: 2022-04-30, device manufacture date: 2019-05-09.Medical device lot #: 9171672, medical device expiration date: 2022-05-31, device manufacture date: 2019-06-20.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 patient was receiving calea parenteral nutrition, and being treated for multi-organ line sepsis after the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was used on them.Microbes identified during the treatment included "candida parapsilosis, klebsiella oxytoca and pseudomonas aeruginosa", as well as "enterobacter", in which a multi-organism infection was considered "unusual".Systemic antimicrobials were given to the patient, and the tunneled central venous catheter was removed.Cross-sectional imaging was also performed to search for the source of the poly-microbial infection, but nothing was found.The patient reportedly continues to receive systemic treatment at this time.Lot #'s 9129750 and 9171672 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.The following information was provided by the initial reporter: "we have been notified of an issue relating to a patient receiving calea parenteral nutrition; the patient is being treated for multi-organ line sepsis following administration of parenteral nutrition.Microbes identified include; candida parapsilosis, klebsiella oxytoca and pseudomonas aeruginosa.Such a multi-organism infection is unusual and all possible sources of it are being followed up, including medication received." patient continues to receive systemic treatment at present.The patient is being treated for multi-organ line sepsis.Microbes identified include candida parapsilosis, klebsiella oxytoca and pseudomonas aeruginosa.Additionally, enterobacter was also isolated in the district hospital.

Manufacturer Narrative

H.6.Investigation summary: there was no samples returned.There is no evidence that posiflush syringe was responsible for this infection.A potential contributory factor maybe other medicinal products in use or administered at the time the patient¿s port was flushed.Based on the information provided, it is more probable than not that the symptoms described may be infection related; it is highly improbable that this infection was produced by the normal saline in the bd posiflush product.During the period 2017-2019, there are no other adverse customer complaint trends for the complaint category of allergic reaction/infection there are no known allergies to normal saline, either topical or within the body.It is most likely that whatever fluid was in the iv line prior to flushing contained inadequately flushed medication or glucose from previous treatments.Dhr: the non-conformances were reviewed for this batch, and there was no record of non-conformance which could contribute or is directly related to the complaint verbatim reported by the customer.

Event Description

It was reported that the patient was receiving calea parenteral nutrition, and being treated for multi-organ line sepsis after the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% was used on them.Microbes identified during the treatment included "candida parapsilosis, klebsiella oxytoca and pseudomonas aeruginosa", as well as "enterobacter", in which a multi-organism infection was considered "unusual".Systemic antimicrobials were given to the patient, and the tunneled central venous catheter was removed.Cross-sectional imaging was also performed to search for the source of the poly-microbial infection, but nothing was found.The patient reportedly continues to receive systemic treatment at this time.Lot #'s 9129750 and 9171672 were reported to have been involved in this event, but it is unknown how many occurrences happened within each lot.The following information was provided by the initial reporter: "we have been notified of an issue relating to a patient receiving calea parenteral nutrition; the patient is being treated for multi-organ line sepsis following administration of parenteral nutrition.Microbes identified include; candida parapsilosis, klebsiella oxytoca and pseudomonas aeruginosa.Such a multi-organism infection is unusual and all possible sources of it are being followed up, including medication received." patient continues to receive systemic treatment at present.The patient is being treated for multi-organ line sepsis.Microbes identified include candida parapsilosis, klebsiella oxytoca and pseudomonas aeruginosa.Additionally, enterobacter was also isolated in the district hospital.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 9140235
• MDR Text Key: 167182977
• Report Number: 9616657-2019-00344
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention