MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH-XS / SF; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306553

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd posiflush-xs / sf was under filled when the package was opened.The following information was provided by the initial reporter: event description: ¿0.9%sodium chloride injection 10ml syringe.As i opened the brand new syringe from the packaging it was only filled with 5ml of air and 5ml of fluid.I didn't use the syringe on the patient, but this is concerning.¿ harm to team member or patient? not applicable.Product was discarded and no photos were taken.

Event Description

No additional information.

Manufacturer Narrative

A device history record review was completed for provided material number (b)(4) and lot number 3226512.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.As neither physical samples nor picture samples were available for return, a thorough sample analysis could not be completed.If the affected samples become available for this incident or any potential future incidents, we would greatly appreciate the opportunity to review them.Based on the investigation results, an exact cause could not be determined for the reported event.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.H3 other text : see narrative below.

• Brand Name: BD POSIFLUSH-XS / SF
• 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: 18743523
• MDR Text Key: 336770722
• Report Number: 9616657-2024-00007
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: (01)30382903065531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042061
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306553
• Device Lot Number: 3226512
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1