POSIFLUSH XS/SF
Received Feb 12, 2026 · Event occurred Feb 3, 2026
Report 9616657-2026-00002 · MDR key 24324843
Device
Generic name
Saline Vascular Access Flush
Manufacturer
Becton, Dickinson And Co.Catalog number
306572
Lot number
4242754
Product problems
- Tear, Rip or Hole in Device Packaging
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306572 AND LOT NUMBER 4242754. THE REVIEW DID NOT REVEAL ANY POSSIBLE NON-CONFORMANCES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE AND THE AFFECTED PHYSICAL SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, A TEAR IN THE PACKAGING WEB WAS OBSERVED. A REVIEW OF MES (MANUFACTURING ENGINEERING SYSTEM) SHOWED NO ISSUES AT THE MULTIVAC DURING THE MANUFACTURING OF THE BATCH. HOWEVER, THERE WERE ENTRIES RELATING TO THE PACKAGING STATION AT THE LINE. BASED ON THE PHYSICAL SAMPLE AND THE ENTRIES ON MES, THE MOST PROBABLE ROOT CAUSE WAS DAMAGE TO THE SHELF CARTON DURING PACKING INTO THE SHIPPER, WHICH IN TURN RESULTED IN THE BLISTER PACKS BEING DAMAGED. THIS IS THE FIRST REPORT RECEIVED FOR THIS TYPE OF ISSUE ON MATERIAL NUMBER 306572 AND LOT NUMBER 4242754. 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.
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
SYRINGE PACKAGE, DAMAGED DUE TO BOX PRESSURE. INCIDENT DATE: ON (B)(6) 2026. NO HARM CAUSED TO A PATIENT ¿ NOT OPENED AND NOT SENT TO CUSTOMER.