PORTEX MANUAL RESUSCITATOR
Received Dec 11, 2023 · Event occurred Nov 16, 2023
Report 9617604-2023-00011 · MDR key 18306449
Device
Generic name
Circulator, Breathing-circuit
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
670003
Lot number
NI
Product problems
- Material Rupture
- Material Rupture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4: LOT NUMBER, EXPIRATION DATE, AND H4: DEVICE MANUFACTURE DATE ARE UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. G5: 510 IS UNKNOWN. H3: OTHER; DEVICE NOT RETURNED TO MANUFACTURER. 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 DEVICE RUPTURED DURING USE IN AN OPERATION. THE PRODUCT HAD BEEN CHECKED BEFORE USE AND THERE WAS NO PROBLEM. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Additional Manufacturer Narrative
D4: INSUFFICIENT INFORMATION WAS PROVIDED TO BE ABLE TO DETERMINE THE FULL UDI.
Additional Manufacturer Narrative
D9: DATE RETURNED TO MFG.: 1/3/2024. ONE DEVICE SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL PACKAGE. TWO PHOTOS WERE INCLUDED FOR EVALUATION, AND A BROKEN BAG WAS OBSERVED. VISUAL INSPECTION CONFIRMED THE COMPLAINT. THE ROOT CAUSE WAS NOT ESTABLISHED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE COMPLAINT FAULT HAS BEEN ESCALATED TO ADDRESS A FULL ROOT CAUSE INVESTIGATION.