MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH SP; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306575

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

Patient Problem Bacterial Infection (1735)

Event Date 01/04/2024

Event Type  Injury  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.The material and lot numbers are unknown.Information gathered by bd regulatory of possible lots sold that would require dhr are as follows: 2278406, 2292178, 2319309, 2334522, 3004720, 3052157, 3060345, 3081788, 3137018, 3151491, 3199055, 3199120 and 3206250.

Event Description

It was reported that undisclosed bd posiflush sp was used on patients diagnosed with r.Pickettii the following information was provided by the initial reporter: the tga has been notified of one or more patient cases presenting with r.Pickettii following the use of the bd posiflush 10 ml pre-filled syringe, where there did not appear to be use of other products identified by recent tga recall actions.The tga is undertaking an investigation to determine the extent of the possible contamination and causal factors.Information required.I require the following information/documents to be provided in relation to the potential breaches of the act and/or therapeutic goods (medical devices) regulations 2002: 1.A list of all products/ models supplied under the artg entries and for each product/ model, provide a list batch numbers and the date of manufacture.Please provide this for the last 2 years or for product supplied still within expiry.If you supply any other products that are sterile solutions containing sodium chloride in volumes not captured by the referenced artg entries, please also provide this information for each model.This can be supplied in table format.2.For each batch listed, provide details of the batch size and distribution information supplied since 1 march 2023 - each facility the batch/ lot has been supplied, the state/ territory, and the number of units supplied to each facility.3.For any products containing a sodium chloride solution, provide details for each key supplier including their address and the key manufacturing steps undertaken at the facility.Key suppliers could include the supply of raw material, mixing or processing, quality control, testing (internal or external), sterilization, packaging, transport, labelling, storage and warehousing.This also includes any sub contracted manufacturers or suppliers, even for a short duration of time.4.Provide details of any reports or complaints received regarding product contamination (bacterial or other) for all batches of the devices in australia and overseas.Please provide dates of the complaint, the product name and details of the batches affected.5.Provide details of any investigation undertaken by the manufacturer to date regarding this issue, including any manufacturer testing of the retention or returned complaint samples.The investigations could include a review of batch manufacturing records, batch deviations/ non-conformances records and review of the batch sterility tests.6.Provided the method and process of sterilization.7.Provide images of the devices and full product labelling, including the instructions for use (ifu).8.Provide all internal (pre-release/ finished product) test reports for each of the batches detailed above for the devices, including the testing related to assurance of sterility parameters.9.Provide information relating to the manufacturer¿s capacity to undertake microbiological testing of products/ retention samples in the event there are any contaminated product batches.

Manufacturer Narrative

A device history record review was completed for provided material number 306575 and potential lot number 2278406, 2292178, 2319309, 2334522, 3004720, 3052157, 3060345, 3081788, 3137018, 3151491, 3199055, 3199120, and 3206250.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.All processes which could affect the sterility of the product have been reviewed and no issues have been found.As samples were unavailable for return, a thorough sample analysis could not be completed.At this time, an exact cause could not be determined for this incident.Bd notes that the bacteria r.Pickettii is a commonly occurring gram negative rod species of bacteria.Due to the thin cell wall in gram-negative bacteria, heat easily physically disrupts 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° c.The bd posiflush¿ products are produced on highly automated manufacturing lines and are terminally sterilised using moist heat sterilisation.Bd uses a sterilisation temperature range of 120.1° c to 124.1° c for a minimum dwell time of 31 minutes for the bd posiflush¿ family of products.

• Brand Name: BD POSIFLUSH SP
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca NJ 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18632804
• MDR Text Key: 334448276
• Report Number: 2243072-2024-00108
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 306575
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other