PORTEX NRFIT CONNECTOR EPIDURAL
Received Jul 18, 2024 · Event occurred May 27, 2024
Report 3011237704-2024-00148 · MDR key 19772253
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Smiths Medical Czech Republic A. SCatalog number
24-1011-64CZ
Lot number
4465055
Product problems
- Loose or Intermittent Connection
- Loose or Intermittent Connection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
B5 - DESCRIBE EVENT OR PROBLEM: ADDITIONAL INFORMATION. H6. HEALTH EFFECT - IMPACT CODE; CORRECTED. H6. EVALUATION CODES: UPDATED. NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. THE REPORTED PRODUCT IS NOT A PART OF BILL OF MATERIALS (BOM) OF THE REPORTED LOT NUMBER, THEREFORE THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE PERFORMED. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.
Description of Event or Problem
THE INNER CANNULA WAS REPLACED WITH ANOTHER WHICH RESOLVED THE ISSUE.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE INNER CANNULA WAS LOOSE, AND THE STAFF WERE UNABLE TO "CLICK" IT BACK INTO PLACE SUCH THAT IT WAS SECURE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.