INTERA 1 3/8" SPECIAL BOLUS NEEDLE
Received Jan 30, 2026 · Event occurred Jan 6, 2026
Report 3015537318-2026-00008 · MDR key 24227113
Device
Generic name
Non-coring (huber) Needle
Manufacturer
Intera Oncology, IncModel number
AP-04013-5Catalog number
AP040135
Lot number
AP040135
Product problems
- Difficult to Flush
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE NEEDLE ARRIVED AT INTERA ONCOLOGY ON (B)(6) 2025 AND IS UNDER EVALUATION. THEREFORE, ONCE THE EVALUATION IS COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
INTERA ONCOLOGY WAS NOTIFIED THAT DURING PUMP PREPARATION FOR AN IMPLANT ON (B)(6) 2026, THE SCRUB TECH WASN'T ABLE TO FLUSH THE PUMP BOLUS PATHWAY WITH LOW DOSE HEPARINIZED SALINE. THEY OPENED THE BACKUP SPECIAL BOLUS NEEDLE AND WAS ABLE TO FLUSH THE PUMP BOLUS PATHWAY. THE PUMP WAS SUCCESSFULLY IMPLANTED AND THE CLINIC SET THE MALFUNCTIONED NEEDLE ASIDE TO BE EXAMINED BY INTERA ONCOLOGY.
Additional Manufacturer Narrative
A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE BOLUS NEEDLE WAS TESTED AT INTERA ONCOLOGY AND THE COMPLAINT ALLEGATION OF THE NEEDLE BEING UNABLE TO BOLUS WAS NOT REPLICATED.
Description of Event or Problem
INTERA ONCOLOGY WAS NOTIFIED THAT DURING PUMP PREPARATION FOR AN IMPLANT ON (B)(6) 2026, THE SCRUB TECH WASN'T ABLE TO FLUSH THE PUMP BOLUS PATHWAY WITH LOW DOSE HEPARINIZED SALINE. THEY OPENED THE BACKUP SPECIAL BOLUS NEEDLE AND WAS ABLE TO FLUSH THE PUMP BOLUS PATHWAY. THE PUMP WAS SUCCESSFULLY IMPLANTED AND THE CLINIC SET THE MALFUNCTIONED NEEDLE ASIDE TO BE EXAMINED BY INTERA ONCOLOGY.