MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH; SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE

Catalog Number	303191
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided by the initial reporter: material: 303191, batch#: 5105648.Rcc received a complaint via phone.Customer states that when the nurse was flushing her iv line with the 10ml posiflush, she started getting a plastic taste in her mouth.Shortly after that, she had a hard time breathing as she is allergic to plastic.Lot number: 5105648.Additional information received on 22-oct-2025: hi, thank you for the follow up.Date of occurrence on (b)(6) 2025.During the iv line flush process with the bd posiflush safe scrub product, i experienced the foul odor/taste in my pharyngeal area on the same side as the iv flush wich resulted in lung congestion requiring the use of my albuterol inhaler.I reported this experience to 2 nurses as well as the nurse manager who was on call.I experienced this several times on (b)(6) 2025 and refused further use of this bd product to flush my iv line.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.
Event or Problem Description
No additional information.

• Brand Name: BD POSIFLUSH
• Common Device Name: SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 23478485
• Report Number: 1911916-2025-00719
• Device Sequence Number: 13325040
• Product Code: QTI
• UDI-Device Identifier: 00382903031917
• UDI-Public: (01)00382903031917(17)280421(10)5105648
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K213955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 303191
• Device Lot Number: 5105648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown