LEUKOSTRIP 13X102MM CTN 50
Received Apr 5, 2022 · Event occurred Mar 14, 2022
Report 8043484-2022-00120 · MDR key 14018435
Device
Generic name
Topical Approximation System
Manufacturer
Smith & Nephew Medical Ltd.Model number
66002880Catalog number
66002880
Lot number
2053A
Product problems
- Contamination
- Contamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, DURING SET UP FOR WOUND TREATMENT, WAS CONFIRMED A FOREIGN SUBSTANCE ADHERED ON THE STRIP IN ONE DRESSING OF A LEUKOSTRIP 13X102MM CTN 50. AS THIS WAS NOTICED BEFORE TREATMENT, THERE WAS NOT ANY PATIENT INVOLVED.
Additional Manufacturer Narrative
INTERNAL COMPLAINT REFERENCE: CASE-(B)(4).
Additional Manufacturer Narrative
H3, H6: THE PRODUCT HAS BEEN RETURNED AND EVALUATED, THE EVENT IS CONFIRMED. VISUAL INSPECTION OF THE DRESSING HAS CONFIRMED THE REPORTED CONTAMINATION, THIS HAS BEEN CONFIRMED TO BE ADDITIONAL ADHESIVE, THIS IS NOT ANY OTHER FORM OF CONTAMINATION. A DOCUMENTATION REVIEW HAS REVEALED PREVIOUSLY CASES WITH A SIMILAR NATURE, THERE ARE NO OPEN CORRECTIVE ACTIONS. THE MANUFACTURING RECORDS CONFIRM THE DEVICE MET THE FINAL PRODUCT SPECIFICATIONS AND CONTAIN NO CONTRIBUTORY FACTORS TO THE REPORTED EVENT, THE ASSOCIATED RISK FILES MITIGATE THIS EVENT TYPE. A REVIEW OF THE MANUFACTURING PROCESS HAS REVEALED THE PROBABLE CAUSE. A PROBABLE CAUSE INCLUDES THE DEFECT WAS NOT PICKED OUT FROM RAW MATERIAL PRIOR TO PRODUCTION, RETRAINING HAS BEEN CONDUCTED, TO REDUCE THE PROBABILITY OF FUTURE OCCURRENCES. NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY, AT THIS STAGE, SMITH AND NEPHEW WILL CONTINUE TO MONITOR FOR ADVERSE TRENDS RELATING TO THE REPORTED EVENT.