BEST PAK Access Needle PK1002Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00853508002225), received between Oct 22, 2018 and Jan 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2020Break; Material Fragmentation; Break; Material Fragmentation

  PROCEDURE PERFORMED : PERCUTANEOUS INSERTION OF PEDICLE SCREWS. LEVELS IMPLANTED L1-S2. IT WAS REPORTED ON (B)(6) 2019, INTRA-OP, THE TAPER TIP OF THE PAK NEEDLE WAS BROKEN AND REMAINS IN THE VERTEBRAL BODY OF THE PATIENT. SOME DRILLING DOWN THE PEDICLE HAD TO BE DONE TO TRY AND RETRIEVE THE PORTION OF THE PAK NEEDLE THAT HAD BROKEN OFF. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9623483 ↗
• MalfunctionJan 22, 2020Break; Break

  IT WAS REPORTED INTRA-OP, THE TIP OF NEEDLE WAS BROKEN AND REMAINED IN PEDICLE BOTH SIDES. ANY COMPLICATION TO THE PATIENT WAS UNKNOWN. UPDATE RECEIVED ON 26 NOV 2019 THE PRODUCT CAME IN CONTACT WITH THE PATIENT AND BROKEN PIECE HAD LEFT INSIDE VERTEBRAL BODY. THERE WAS COMPLICATION TO THE PATIENT AS A RESULT OF THIS EVENT. SURGEON WILL DISCUSS WITH PATIENT FOR ANY REVISION SURGERY TO EXPLANT THE BROKEN TIPS.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9618390 ↗
• MalfunctionOct 22, 2018Break

  DURING THE PROCEDURE, THE DISTAL TIP OF THE CANNULA BROKE OFF INSIDE THE VERTEBRAL BODY OF THE PATIENT. THE SURGEON ATTEMPTED TO REMOVE THE TIP, BUT IT WAS DETERMINED THIS WOULD CAUSE MORE HARM THAN LEAVING THE TIP IN PLACE. IT WAS DISCLOSED TO THE PATIENT THAT THERE WAS A PURPOSEFULLY RETAINED FOREIGN BODY. NO FURTHER COMPLICATIONS AROSE FROM THE PROCEDURE, AND IT WAS COMPLETED AS PLANNED. THE BROKEN TROCAR WAS SAVED, IMAGES WERE CAPTURED, AND IT WILL BE RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. MANUFACTURER RESPONSE FOR TROCAR, PAK NEEDLE - TROCAR (PER SITE REPORTER). WE HAVE REQUESTED TO RETURN THE DEVICE FOR FAILURE ANALYSIS. FURTHER RESPONSE FROM THE MANUFACTURER WILL BE SHARED WITH MEDSUN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7989983 ↗