CARDINAL HEALTH
Received Jun 23, 2025
Report 1423537-2025-00263 · MDR key 22309637
Device
Generic name
Gastrointestinal Tubes With Enteral Specific Connectors
Manufacturer
Cardinal Health 200, LlcModel number
8888266130ECatalog number
8888266130E
Lot number
2301901464
Product problems
- Difficult to Remove
- Difficult to Remove
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDED THE 510K NUMBER IN SECTION G4 PMA/510(K)NUMBER FIELD.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE ANTI REFLUX VALVE IS STUCK IN THE BLUE PORT AND WILL NOT COME OUT HOWEVER, PRIOR TO SENDING THE SAMPLE FOR EVALUATION, ONE OF THE CENTRAL SUPPLY FOLKS WAS ABLE TO FORCEFULLY REMOVE THE ARV BUT THE NURSES COULD NOT.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY-PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS EVALUATED, AND THE REPORTED CONDITION WAS NOT OBSERVED. AS SUCH, A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED TO ADDRESS THE REPORTED CONDITION. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.