PORTEX CUFF PRESSURE MONITORING
Received May 5, 2023 · Event occurred Apr 24, 2023
Report 3012307300-2023-05216 · MDR key 16878800
Device
Generic name
Cuff Inflator Pressure Gauge
Manufacturer
Smiths Medical International, Ltd.Catalog number
100/568/000
Lot number
4313438
Product problems
- Device Emits Odor
- Device Emits Odor
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE AVAILABLE FOR EVALUATION; H3. DEVICE EVALUATED BY MANUFACTURER AND H6. EVALUATION CODES: UPDATED. ONE NON-DECONTAMINATED SAMPLE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING. PRODUCT WAS PACKED IN 5 POLYBAGS. THE REPORTED OFFENSIVE ODOR" WAS NOT NOTICED. THE RETURNED PRODUCT HAD COMMON ODOR IN COMPARISON WITH OTHER CUFF INFLATORS (RUBBER SMELL). A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED AS THE COMPLAINT COULD NOT BE CONFIRMED. NO ACTION TAKEN.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THERE WAS AN ODOR FROM THE PRODUCT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Additional Manufacturer Narrative
B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED, DAY IS UNKNOWN. D4: UDI NUMBER IS UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. G5: 510K IS BLANK DEVICE IS EXEMPT. 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.