MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SALINE FILL CE; 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 01/07/2024

Event Type  Injury  

Event Description

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), sterilisation, 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 sterilisation.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.The requested information must be provided no later than 6 february 2024.Customer event 2: nsw health: ¿ two rural nsw hospitals relating to one patient testing positive to r.Pickettii (via blood culture isolates from one hospital), renal unit, emergency department and dialysis unit where posiflush was used for iv flush.Unknown - bd has requested tga provide facts of the infection/contamination incidents by 8jan2023.

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.

Event Description

Duplicate complaint.

Manufacturer Narrative

Pr (b)(4) - follow mdr for correction / duplicate.Following the submission of the initial mdr, it was determined that this was a duplicate to complaint pr (b)(4).Appropriate mdrs will be filed under that pr.

• Brand Name: SYRINGE 10ML SALINE FILL CE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18579754
• MDR Text Key: 333730332
• Report Number: 3002682307-2024-00010
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065752
• UDI-Public: (01)00382903065752
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306575
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• 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