ASPIRATING NEEDLE TIP 23GA
Received Jan 6, 2025 · Event occurred Dec 10, 2024
Report 3011137372-2025-00009 · MDR key 21083088
Device
Generic name
Needle, Aspiration And Inject
Manufacturer
Teleflex MedicalCatalog number
507454
Lot number
N/A
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE CUSTOMER'S PHOTOS DEPICT A DEVICE, AND THE REPORTED COMPLAINT COULD NOT BE CONFIRMED BASED ON THE PHOTOS PROVIDED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED AS NO SAMPLE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE CUSTOMER'S PHOTOS DEPICT A DEVICE, AND THE REPORTED COMPLAINT COULD NOT BE CONFIRMED BASED ON THE PHOTOS PROVIDED. PRODUCT DRAWING WAS REVIEWED. THE CUSTOMER PHOTO PROVIDED DOES NOT MATCH PRODUCT DRAWING. SAP WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO (B)(4). TELEFLEX WILL CONTINUE TO MONITOR AND TREND COMPLAINTS OF THIS NATURE.
Description of Event or Problem
IT WAS REPORTED THAT "WHILE DOING A ROBOTIC ESOPHAGECTOMY WITH [DOCTOR] WE WERE ATTEMPTING TO USE THE MEDIASTINOSCOPY NEEDLE TO DELIVER A INTERCOSTAL NERVE BLOCK. WHILE GOING THROUGH THE INCISION SITE THE NEEDLE BROKE OFF IN THE PATIENT AND IS LOST. THIS HAS HAPPENED ONCE BEFORE LAST FEBRUARY, HOWEVER, IT WAS RIGHT IN THE INCISION SITE AND ABLE TO BE FOUND EASILY. WE HAVE HAD MULTIPLE NEEDLES BREAK OUTSIDE OF THE PATIENT BECAUSE THEY SEEM TO BE VERY FLIMSY". NO MEDICAL INTERVENTION REQUIRED. THE PATIENT STATUS IS REPORTED AS "FINE".
Description of Event or Problem
IT WAS REPORTED THAT "WHILE DOING A ROBOTIC ESOPHAGECTOMY WITH [DOCTOR] WE WERE ATTEMPTING TO USE THE MEDIASTINOSCOPY NEEDLE TO DELIVER AN INTERCOSTAL NERVE BLOCK. WHILE GOING THROUGH THE INCISION SITE THE NEEDLE BROKE OFF IN THE PATIENT AND IS LOST. THIS HAS HAPPENED ONCE BEFORE LAST (B)(6), HOWEVER, IT WAS RIGHT IN THE INCISION SITE AND ABLE TO BE FOUND EASILY. WE HAVE HAD MULTIPLE NEEDLES BREAK OUTSIDE OF THE PATIENT BECAUSE THEY SEEM TO BE VERY FLIMSY". NO MEDICAL INTERVENTION REQUIRED. THE PATIENT STATUS IS REPORTED AS "FINE".
Additional Manufacturer Narrative
(B)(4) OTHER REMARKS: N/A CORRECTED DATA: N/A.