VENTURI NEEDLE BLUNT 14GAX4"
Received Jan 15, 2020 · Event occurred Jan 8, 2020
Report 3011137372-2020-00020 · MDR key 9592186
Device
Generic name
Needle, Aspiration And Injecti
Manufacturer
Teleflex MedicalCatalog number
502600
Lot number
UNKNOWN
Product problems
- Flaked
- Flaked
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
QN#(B)(4). DEVICE HISTORY RECORD WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO (B)(4) . AS STATED IN THE COMPLAINT- THE DEVICE IS NOT NEW. THE PARTICULATE REPORTED WAS NOT PRESENT IN THE NEEDLE DURING PREVIOUS USAGE. IT CAN BE ASSUMED THAT THE PARTICULATE WAS INTRODUCED DURING THE PRECEDING CLEANING CYCLE RATHER THAN IN MANUFACTURING. A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. A DIMENSIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. A FUNCTIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. NO CONFIRMED COMPLAINTS WERE RECEIVED IN THIS RANGE WITH THE SAME ISSUE. SAP WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO (B)(4) . AS STATED IN THE COMPLAINT- THE DEVICE IS NOT NEW. THE PARTICULATE REPORTED WAS NOT PRESENT IN THE NEEDLE DURING PREVIOUS USAGE. IT CAN BE ASSUMED THAT THE PARTICULATE WAS INTRODUCED DURING THE PRECEDING CLEANING CYCLE RATHER THAN IN MANUFACTURING.
Description of Event or Problem
IT WAS REPORTED THAT WHEN TURNING ON THE VENT WHICH SHOOTS OUT AIR THE PATIENTS THROAT WAS SPRAYED WITH PARTICLES WHICH APPEARED TO BE METAL SHAVINGS. THE PATIENT WAS UNINJURED AND THE SURGEON WAS ABLE TO SUCK OUT THE PARTICLES. THIS IS NOT A NEW ITEM AND THE SURGEONS CONCERN IS THAT IT WOULD BE A CONTINUED ISSUE WITH THIS OR OTHER 502600 VENT NEEDLES WHICH THEY HAVE IN MULTIPLE SETS.
Additional Manufacturer Narrative
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
Description of Event or Problem
IT WAS REPORTED THAT WHEN TURNING ON THE VENT WHICH SHOOTS OUT AIR THE PATIENTS THROAT WAS SPRAYED WITH PARTICLES WHICH APPEARED TO BE METAL SHAVINGS. THE PATIENT WAS UNINJURED AND THE SURGEON WAS ABLE TO SUCK OUT THE PARTICLES. THIS IS NOT A NEW ITEM AND THE SURGEONS CONCERN IS THAT IT WOULD BE A CONTINUED ISSUE WITH THIS OR OTHER 502600 VENT NEEDLES WHICH THEY HAVE IN MULTIPLE SETS.