POSIFLUSH XS/SF
Received Sep 4, 2025 · Event occurred Jul 26, 2025
Report 9616657-2025-00018 · MDR key 22973274
Device
Generic name
Saline Vascular Access Flush
Manufacturer
Becton, Dickinson And Co.Catalog number
306572
Lot number
UNKNOWN
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
Description of Event or Problem
A PATIENT DEVELOPED PRURITIC ERYTHEMATOUS PAPULES ON THE BODY AND FACE. RESOLUTION WITH 1 AMPOULE OF POLARAMINE 1 MG. NO FURTHER TREATMENT OR TOPICAL MEDICATION, NO UNUSUAL FOODS. NO DYSPNEA, RESPIRATORY DISCOMFORT OR PHARYNGEAL OEDEMA. SATURATION AND HD STABLE. HISTORY OF SIMILAR EPISODE DURING RECENT HOSPITALIZATION. HYPOTHESIS: POSSIBLE REACTION TO PRE-FILLED RINSING SOLUTIONS. NO RECURRENCE WITH USE OF NACL. ADDITIONAL INFORMATION RECEIVED ON 21-AUG-2025 COULD YOU CONFIRM WHETHER THE STATEMENT "HISTORY OF A SIMILAR EPISODE IN A RECENT HOSPITALIZATION" REFERS TO THE SAME PATIENT OR ANOTHER PATIENT? COULD YOU ALSO TELL US THE DATE OF THE EVENT MENTIONED IN THIS CONTEXT? THIS MENTION REFERS TO THE SAME PATIENT, THE SIMILAR EPISODE HAD TAKEN PLACE ON (B)(6) 2025.
Additional Manufacturer Narrative
AS NO PHYSICAL SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.