N/A TIN3018Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403043819), received between Dec 31, 2020 and Oct 5, 2023 — classified as 6 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 23, 2021Open, Classified

   Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.

   Z-2249-2021 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2023Packaging Problem; Packaging Problem

  NEEDLE UNSHEATHED IN PACKAGING. WE HAVE HAD A SAFETY CONCERN REGARDING A CAREFUSION ILLINIOS STERNAL/ILIAC NEEDLE 18G X 3" REF TIN3018 BATCH 0001493219 EXP 30/09/27 THE ASPIRATION NEEDLE HAD BECOME UNSHEATHED FROM THE SAFETY TIP AND WAS POKING OUT THE SIDE OF THE PACKET. THIS OCCURRED INSIDE THE CARDBOARD BOX PACKAGING. IT COULD HAVE CAUSED A NEEDLE STICK INJURY. I HAVE PHOTOS, IF YOU REQUIRE THEM. MARIE DIXON PER FOLLOWUP: NO PATIENT INVOLVEMENT, IT WAS FOUND BY HAEMATOLOGY CONSULTANT AND REGISTRAR. NO NEEDLESTICK INJURY OCCURRED AS THEY NOTICED IT AS THEY WERE PULLING IT OUT OF THE BOX, SO NOT REPORTED, OTHER THAN TO LET ME KNOW TO NOTIFY YOU. THE PHYSICAL NEEDLE WAS DISCARDED IMMEDIATELY INTO A SHARPS BIN TO PREVENT ANYBODY FROM HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877627 ↗
• MalfunctionOct 20, 2022Packaging Problem; Packaging Problem

  IMPROPERLY MOUNTED PROTECTION ON THE TROCAR LEADING TO A PERFORATION OF THE PACKAGING. CLINICAL CONSEQUENCES OBSERVED: VERY HIGH RISK OF INJURY, BUT NO ACTUAL INJURY REPORTED PRECAUTIONARY MEASURES AND ACTIONS TAKEN: WITHDRAWAL FROM STOCK. DEVICE AVAILABLE FOR EXPERTISE BY THE SUPPLIER: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642551 ↗
• MalfunctionMar 15, 2022Packaging Problem; Packaging Problem

  DUE TO STOCK INSPECTION WE¿VE IDENTIFIED 2 X 18G JAMSHIDI BONE MARROW BIOPSY NEEDLE (LOT 0001395413) WITH NEEDLE PROTECTOR TO BECOME DETACHED WITHIN THE PACKAGING, WHICH LET NEEDLE OF THE DEVICE TO PUNCTURE THE PACKAGING COMPROMISING THE STERILE BARRIER. I WILL BE REJECTING ALL OUR STOCK OF (B)(4) X (LOT 0001395413 & 0001390010) AND SENDING BACK TO YOU AS IT COULD RESULT IN POTENTIAL INJURY FOR OUR WORKERS OR CUSTOMERS. NEEDLE STICKING THROUGH PACK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13770193 ↗
• MalfunctionNov 17, 2021Disconnection; Disconnection

  THE NEEDLE PACKAGING WAS OPENED AND YOU CAN CLEARLY SEE THE NEEDLE HAS NOT BEEN FINISHED IN PRODUCTION AS THE PARTS ARE SEPARATE. THE BLUE HANDLE IS NOT ATTACHED. PICTURES ATTACHED AND THE SAMPLE CAN BE RETURNED IF REQUIRED? NOT USED ON PATIENT. THE OUTER PACKAGE WAS UNOPENED AND SEALED APPROPRIATELY. WHEN WE OPENED THE PACKAGE, WE FOUND THE FAULTY ITEM INSIDE. THE NEEDLE PACKAGING WAS INTACT AND SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829172 ↗
• MalfunctionDec 31, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS FOUND THAT PERFORMING THE PUNCTURE PROCEDURES, THE ILLINOIS 18GAX3 "BONE MARROW ASPIRATION NEEDLES ARE VERY FRAGILE AND BEND IN MOST OF THE PROCEDURES, A PHOTOGRAPH IS ATTACHED, LIKEWISE ON TUESDAY, DECEMBER 08, THE CLIENT WILL BE ATTENDED HOSPITAL INFANTIL DE MÉXICO AND THE USER AREAS TO COLLECT MORE INFORMATION AND PRODUCT SAMPLES, FOR DELIVERY TO BD. PATIENT IMPACT: TRAUMA DUE TO MULTIPLE PUNCTURES TO PATIENTS INVOLVED IN EACH PROCEDURE, AND EVEN MORE BEING MINORS (UNDER AGE). ((B)(6), (B)(6) 2020): TO WHICH CATALOG AND BATCH DOES EACH OF THE PRODUCTS IN THE IMAGE REGARD? CUSTOMER REPORTS BOTH BATCHES 0001336523 AND 0001231557; WAS THERE ANY FURTHER PATIENT IMPACT? NONE, THERE WAS ONLY THE MULTIPLE PUNCTURES. WAS MEDICAL INTERVENTION REQUIRED? NO. ARE THERE PHYSICAL SAMPLES AVAILABLE FOR EVALUATION? YES, FROM BATCH 0001336523..

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102423 ↗
• MalfunctionDec 31, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS FOUND THAT PERFORMING THE PUNCTURE PROCEDURES, THE ILLINOIS 18GAX3 "BONE MARROW ASPIRATION NEEDLES ARE VERY FRAGILE AND BEND IN MOST OF THE PROCEDURES, A PHOTOGRAPH IS ATTACHED, LIKEWISE ON (B)(6) 2020 THE CLIENT WILL BE ATTENDED (B)(6) HOSPITAL AND THE USER AREAS TO COLLECT MORE INFORMATION AND PRODUCT SAMPLES, FOR DELIVERY TO BD. PATIENT IMPACT: TRAUMA DUE TO MULTIPLE PUNCTURES TO PATIENTS INVOLVED IN EACH PROCEDURE, AND EVEN MORE BEING MINORS (UNDER AGE). ((B)(6), (B)(6) 2020): TO WHICH CATALOG AND BATCH DOES EACH OF THE PRODUCTS IN THE IMAGE REGARD? CUSTOMER REPORTS BOTH BATCHES 0001336523 AND 0001231557. WAS THERE ANY FURTHER PATIENT IMPACT? NONE, THERE WAS ONLY THE MULTIPLE PUNCTURES. WAS MEDICAL INTERVENTION REQUIRED? NO. ARE THERE PHYSICAL SAMPLES AVAILABLE FOR EVALUATION? YES, FROM BATCH 0001336523.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102419 ↗