PORTEX MANUAL RESUSCITATION ACCESSORIES
Received Sep 16, 2022 · Event occurred Mar 16, 2020
Report 3012307300-2022-19434 · MDR key 15437286
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Smiths Medical International, Ltd.Model number
8501Catalog number
8501
Lot number
200107
Product problems
- Packaging Problem
- Packaging Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. THE DEVICE HISTORY RECORD (DHR) WAS AT THE SUPPLIER. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. REVIEW OF CHANGES RELEVANT TO THE PRODUCT AND LOT NUMBERS REPORTED DETERMINED THAT THE ABSENCE OF THE PRODUCT EXPIRATION DATE WAS NOT THE RESULT OF A MANUFACTURING RELATED ISSUE, BUT PART OF A CHANGE TO OUR PRODUCT'S PACKAGING. AS SIMILAR PRODUCTS FROM OTHER, NON-SMITHS BRANDS DO NOT FEATURE PRINTED EXPIRATION DATES, IT WAS REQUESTED THAT THE PACKAGING OF THE RESUSCITATORS BE MODIFIED TO NO LONGER INCLUDE THESE DATES. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT NO EXPIRATION DATE LISTED. NO PATIENT INJURY WAS REPORTED.