SYRINGE 5ML HEPARIN 10 UNIT
Received May 5, 2025 · Event occurred Apr 30, 2025
Report 1911916-2025-00325 · MDR key 21962301
Device
Generic name
Heparin, Vascular Access Flush
Manufacturer
Becton DickinsonCatalog number
306414
Lot number
429953N
Product problems
- Infusion or Flow Problem
- Infusion or Flow Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INITIAL MDR SUBMISSION. 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
MATERIAL #306414, LOT #429953N. VERBATIM: THIS IS OUR 6TH REPORT OF FINDING A SYRINGE THAT IS EMPTY OF ANY FLUID, BUT THE SYRINGE IS PULLED BACK, CAPPED AND PACKAGED AS THOUGH THERE IS FLUID IN THE SYRINGE. THE FLUID IS CLEAR, SO THE RISK IF THIS IS NOT NOTICED IS THAT AIR IS INJECTED INTO THE PATIENT INSTEAD OF FLUID. IF THIS IS A SMALL INFANT OR A CHILD WITH A RIGHT TO LEFT SHUNT, THE CONSEQUENCES COULD BE CATASTROPHIC.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF (B)(6) AND THE COMPLAINT WILL BE CANCELLED. THE ASSOCIATED MDR WILL BE VOID.