BD POSIFLUSH
Received Nov 5, 2025 · Event occurred Aug 16, 2025
Report 1911916-2025-00719 · MDR key 23478485
Device
Generic name
Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device
Manufacturer
Bd Medical (bd West) Medical SurgicalCatalog number
303191
Lot number
5105648
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
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.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Description of Event or Problem
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.