POSIFLUSH XS/SF
Received Dec 5, 2025 · Event occurred Nov 13, 2025
Report 9616657-2025-00023 · MDR key 23730141
Device
Generic name
Saline Vascular Access Flush
Manufacturer
Becton, Dickinson And Co.Catalog number
306572
Lot number
4050231
Product problems
- Short Fill
- Short Fill
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
12/10/2025 ADDITIONAL INFORMATION RECEIVED; PATIENT GRID UPDATED.
Description of Event or Problem
12/10/2025 ADDITIONAL INFORMATION RECEIVED: "REGARDING THE CURRENT COMPLAINT, I CAN CONFIRM THAT, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER CONCERNED, THERE HAS BEEN NO USE ON A PATIENT".
Additional Manufacturer Narrative
INVESTIGATION RESULTS: THE NON-CONFORMANCE'S WERE REVIEWED FOR THIS BATCH, AND THERE WERE NO POSSIBLE NON-CONFORMANCE'S WHICH COULD CONTRIBUTE TO THE COMPLAINT VERBATIM REPORTED BY THE CUSTOMER. AS THERE WAS NO SAMPLE OR PHOTOGRAPH AVAILABLE FOR THIS COMPLAINT, WE WERE UNABLE TO DETERMINE THE ROOT CAUSE. IF A SAMPLE BECOMES AVAILABLE, THE INVESTIGATION WILL BE REOPENED.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
Description of Event or Problem
THE PRE-FILLED SYRINGE WITH REFERENCE NUMBER (B)(4), NORMALLY CONTAINING 10 ML, WAS ONLY FILLED WITH 3 ML. UNFORTUNATELY, THE CUSTOMER DID NOT SEND US ANY IMAGES TO ILLUSTRATE THE DEFECT. NEVERTHELESS, WE WOULD LIKE TO POINT OUT THAT THE CUSTOMER DID NOT REPORT ANY ADDITIONAL DAMAGE RELATED TO THE APPEARANCE OF THE SYRINGE.