MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH PREFILLED SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

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

Patient Problem Insufficient Information (4580)

Event Date 12/22/2023

Event Type  Injury  

Event Description

It was reported that bd posiflush prefilled syringe was used on a patient who developed a blood infection.The following information was provided by the initial reporter: bd has received information from bfarm on dec 22nd that the customer has found ralstonia pickettii in blood culture and stem cell cultures.Bfarm case (b)(4).Bfarm claims, that there are common genome sequences in the isolate from wuerzburg and an isolate in australia, where a product from legency remedies private inc was contaminated and recalled.Hospital is using posiflush, bfarm has sent additional information indicating a link between the bd product and the contamination on jan 24, 2024.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.Below is the answer which was shared with bfarm."bd is aware of the recent fda communication regarding the presence of ralstonia picketti in saline products manufactured by nurse assist.We are not using nurse assist as supplier for manufacturing our bd posiflush products.Bd notes that the bacteria ralstonia picketti is a commonly occurring gram negative rod species of bacteria.Due to the thin cell wall in gram-negative bacteria, heat can easily physically disrupt it causing the cell to be more susceptible to osmotic pressure and degradation.Gram negative bacteria are typically killed at temperatures in excess of 60 degrees celsius.Bd¿s pre-filled saline syringe product, posiflush® is produced on highly automated manufacturing lines and is terminally sterilized using moist heat sterilization.Bd uses a sterilization temperature range of 120.1 degrees celsius to 124.1 degrees celsius for a minimum dwell time of 31 minutes for the posiflush® family of products." h3 other text : see narrative note.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 3194284.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.As samples were unavailable for return, a thorough sample analysis could not be completed.Bd is aware of the recent fda communication regarding the presence of ralstonia picketti in saline products manufactured by nurse assist.We are not using nurse assist as supplier for manufacturing our bd posiflush products.Bd notes that the bacteria ralstonia picketti is a commonly occurring gram negative rod species of bacteria.Due to the thin cell wall in gram-negative bacteria, heat can easily physically disrupt it causing the cell to be more susceptible to osmotic pressure and degradation.Gram negative bacteria are typically killed at temperatures in excess of 60 degrees celsius.Bd¿s pre-filled saline syringe product, posiflush® is produced on highly automated manufacturing lines and is terminally sterilized using moist heat sterilization.Bd uses a sterilization temperature range of 120.1 degrees celsius to 124.1 degrees celsius for a minimum dwell time of 31 minutes for the posiflush® family of products.H3 other text : see narrative below.

Event Description

No additional information.

• Brand Name: BD POSIFLUSH PREFILLED SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18751795
• MDR Text Key: 335932733
• Report Number: 9616657-2024-00008
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 3194284
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other