DBD-STERILE PRE OP PACK
Received Mar 18, 2024 · Event occurred Apr 20, 2023
Report 3004122598-2024-00029 · MDR key 18927204
Device
Generic name
Dbd-sterile Pre Op Pack
Manufacturer
Productos Medline S.a. De C.v.Model number
DYNDA2654ALot number
22JBU450
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT A CONTROL SYRINGE COMPONENT WAS "DIFFERENT" FROM WHAT IT PREVIOUSLY WAS. 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. A PHOTO WAS PROVIDED FOR REVIEW. THE PHOTO SHOWED TWO (2) SYRINGES WITH THE LEFT SYRINGE LABELED "EASILY DISCONNECTS" AND THE RIGHT SYRINGE LABELED "UNBALE TO DISCONNECT." NO NOTICEABLE DIFFERENCES BETWEEN THE SYRINGES WAS SHOWN AND NO DAMAGE OR DEFECTS WERE OBSERVED. NO PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION. 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
IT WAS REPORTED THAT A CONTROL SYRINGE COMPONENT WAS "DIFFERENT" FROM WHAT IT PREVIOUSLY WAS.