LUMBAR PUNCTURE TRAY
Received Dec 17, 2025 · Event occurred Nov 20, 2025
Report 3004122598-2025-00015 · MDR key 23833239
Device
Generic name
Lumbar Puncture Tray
Manufacturer
Productos Medline, S.a. De C.v.Catalog number
DYNDH1160
Lot number
25EB0399
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATED G3, G6, H6.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE RUBBER STOPPER, INSIDE THE SYRINGE IS "FALLING OFF". DUE TO THIS, A NEW SYRINGE WAS USED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
RUBBER STOPPER IN SYRINGE IS "FALLING OFF".