Jamshidi TJC4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403044052), received between Feb 15, 2022 and Aug 22, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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-2247-2021 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED METAL SHAVINGS FROM JAMSHIDI. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DEFECT DESCRIPTION: METAL SHAVINGS FROM JAMSHIDI. RESPONSE RECEIVED : AUGUST 5, 2024. 1. KINDLY PROVIDE THE MATERIAL NUMBER AND BATCH/LOT NUMBER OF THE PRODUCT. 500357 / UNKNOWN LOT. 2. KINDLY PROVIDE THE DATE OF EVENT. (B)(6) 2024. 3. CAN YOU SHARE ANY PHYSICAL SAMPLE IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO PHYSICAL SAMPLE AVAILABLE. 4. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? COMPONENT FLAKED METAL PIECES OFF ONTO THE BONE BIOPSY SAMPLE. 5. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING. 6. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? CUSTOMER RESPONSE RECEIVED PLEASE FIND THE BELOW FILE. 1. WHAT WAS THE IMPACT TO THE PATIENT? NO COMPLICATION STATED. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 3. WAS THIS ISSUE REPORTED EARLIER TO BD? IF YES, PLEASE PROVIDE COMPLAINT REFERENCE NUMBER. THERE WAS AN EARLIER COMPLAINT REPORTED IN MAY (B)(4) HOWEVER, THIS IS A SEPARATE INCID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024296 ↗
• MalfunctionAug 19, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT METAL SHAVINGS FROM JAMSHIDI. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. METAL SHAVINGS FROM JAMSHIDI. CUSTOMER RESPONSE ON AUG 02, 2024. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? METAL SHAVINGS FLAKED OFF FROM THE JAMSHIDI NEEDLE. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING. 3. WHAT WAS THE IMPACT TO THE PATIENT? NO. 4. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 5. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? (B)(6) 2024. 6. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO. 7. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? SEE PHOTOS 8. WAS THIS REPORTED EARLIER TO BD? IF YES, PLEASE PROVIDE COMPLAINT REFERENCE NUMBER. NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999690 ↗
• MalfunctionJun 1, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT JAMSHIDI MPN TJC4011 ARE LEAVING METAL BITS AND SHAVINGS IN THE SPECIMENS THEY ARE RETRIEVING. WE HAVE HAD SEVERAL ISSUES WITH THESE BD JAMSHIDI NEEDLES IN OUR BONE MARROW PROCUREMENT DEPARTMENT. (THEY COME IN CUSTOM MEDLINE BIOPSY KITS AND THIS HAS BEEN REPORTED TO THEM AS WELL.) THEY ARE LEAVING METAL BITS AND SHAVINGS IN THE SPECIMENS THEY ARE RETRIEVING. I HAVE A FEW PHOTO EXAMPLES. THESE ARE ALL FROM JAMSHIDI MPN TJC4011. THERE WERE OTHER INCIDENTS WHERE THE PROVIDERS DID NOT GET PHOTOS AND ALSO WHERE THE PATHOLOGY REPORT CAME BACK WITH METAL SHAVINGS IN IT. THIS HAS BECOME SUCH AN ISSUE THE PROVIDERS ARE REFUSING TO USE THE BD JAMSHIDI NEEDLES AND NOW WANT THEM REMOVED FROM OUR PACKS AND SHELVES. TODAY I WAS PERFORMING A BONE MARROW BIOPSY AND NOTICED SOME SLIGHT RESISTANCE WHEN EXTRACTING THE BONE MARROW FROM THE JAMSHIDI. UPON OBSERVING THE CORE BIOPSY, I NOTICED A METAL SHAVING IMBEDDED IN THE BIOPSY. THE TEETH ON THE END OF THE JAMSHIDI ALSO APPEARED TO BE UNEVEN (THE SHAPE OF THE TEETH APPEARED NORMAL). I LEFT THE METAL ON THE BIOPSY FOR PROCESSING, SO I'M NOT SURE IF THIS WILL ALSO BE REPORTED BY PATHOLOGY. TO MY KNOWLEDGE THIS IS THE 3R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19443408 ↗
• MalfunctionMay 31, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT PIECE OF THE JAMSHIDI NEEDLE FLAKING OFF. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PIECE OF THE JAMSHIDI NEEDLE FLAKING OFF. FOLLOW-UP: CUSTOMER RESPONSE ON (B)(6) 2024. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? IT WAS REPORTED THAT THE ¿METAL PIECES FLAKED OFF¿ INTO THE SPECIMEN. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING USE. 3. DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? FOR BOTH LOT # 0001515801 AND 0001508587. NO MEDICAL INTERVENTION, SERIOUS INJURY, OR FOLLOW-UP CARE HAS BEEN REPORTED. 4. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY FOR BOTH LOT # 0001515801 AND 0001508587? EXACT DATES NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19436159 ↗
• MalfunctionMay 31, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT PIECE OF THE JAMSHIDI NEEDLE FLAKING OFF. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PIECE OF THE JAMSHIDI NEEDLE FLAKING OFF FOLLOW-UP: CUSTOMER RESPONSE ON (B)(6) 2024. 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? IT WAS REPORTED THAT THE ¿METAL PIECES FLAKED OFF¿ INTO THE SPECIMEN. 2. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING USE. 3. DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? FOR BOTH LOT # 0001515801 AND 0001508587. NO MEDICAL INTERVENTION, SERIOUS INJURY, OR FOLLOW-UP CARE HAS BEEN REPORTED. 4. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY FOR BOTH LOT # 0001515801 AND 0001508587? EXACT DATES NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19436150 ↗
• MalfunctionOct 3, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT DOES NOT HAVE A SANITARY REGISTRATION NUMBER ON THE PACKAGING ACCORDING TO THE PROVISIONS OF COFEPRIS HIGH DIRECTIVES, SINCE IT IS A MEASURE TO AVOID THE ENTRY OF COUNTERFEIT, ALTERED AND/OR ADULTERATED SUPPLIES. EMAIL TRANSLATION: A FEW DAYS AGO, 2 PIECES OF HAMSHIDI NEEDLE (OR HAMSHIDI TYPE) WERE DETECTED IN THE WAREHOUSE THAT DO NOT HAVE A SANITARY REGISTRATION NUMBER ON THE PACKAGING. IN ACCORDANCE WITH THE PROVISIONS OF THE HIGH SANITARY DIRECTIVE OF COFEPRIS, ENSURING THAT MEDICINES AND OTHER HEALTH SUPPLIES HAVE A SANITARY REGISTRATION, ALPHA NUMERICAL KEY OR ANY OTHER AUTHORIZATION OR NOTIFICATION IS ONE OF THE MEASURES TO PREVENT THE ENTRY OF FALSIFIED, ALTERED AND / OR ADULTERATED SUPPLIES INTO THE SUPPLY CHAIN, SO I ASK YOU TO CAREFULLY REVIEW THIS ISSUE WITH THE SUPPLIERS OF THESE SUPPLIES (OC 1847 AND 1853). NOTE: I REQUESTED TO QUARANTINE THE SUPPLIES UNTIL THIS SITUATION IS CLARIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528389 ↗
• InjuryApr 21, 2022Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT "JAMSHIDI AND GOT LODGED IN THE TISSUE ABOVE THE ILIAC CREST." VERBATIM: SRG-VH-TJC4011-SAMPLE SLID OUT OF THE JAMSHIDI AND GOT LODGED IN THE TISSUE ABOVE THE ILIAC CREST. REQUIRED PHYSICIAN TO CUT TISSUE AND REMOVE WITH FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14173381 ↗
• MalfunctionFeb 15, 2022Contamination; Contamination

  THE PRODUCT HAS A HAIR INSIDE ITS PACKAGE, THE ISSUE WAS NOTICED BY DISTRIBUTOR AT THE TIME OF DELIVERING IT TO CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535499 ↗