BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE PRECISIONGLIDE 30X1/2IN

    MDR report key: 11586629 · Received March 29, 2021

    Report

    Report Number
    3003916417-2021-00066
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 2, 2021
    Report Date
    May 4, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-03. H6: INVESTIGATION SUMMARY: TO AID IN THE INVESTIGATION, THREE SAMPLES AND SIX PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. EACH SAMPLE RECEIVED HAD THE PLASTIC SHIELD. A VISUAL INSPECTION WAS PERFORMED UNDER A 30X MICROSCOPE AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. IN THE SIX PHOTOS PROVIDED, TWO SHOW A HUMAN HAND, TWO SHOW A NEEDLE ASSEMBLY WITH AN EPOXY DRIP OVER AT THE BOTTOM PART OF THE NEEDLE HUB, ONE SHOWS A NEEDLE TIP WITH WHAT APPEARS TO BE FOREIGN MATTER OVER THE NEEDLE SURFACE, AND ONE SHOWS WHAT IS LABELED AS "PATIENT SKIN TEAR PICTURE." A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 990913, LOT NUMBER 0182656. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. IF ANY EPOXY IS ON THE NEEDLE, THIS COULD HAVE BEEN INDUCED BY A JAM AT THE CANNULATOR. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. A PROBABLE ROOT CAUSE COULD NOT BE OFFERED AS THERE WERE NO DEFECTS OBSERVED ON THE SAMPLES RETURNED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE PRECISIONGLIDE 30X1/2IN HAD EPOXY ON THE NEEDLE. IT WAS DISCOVERED ON 300 OCCASIONS THAT THE NEEDLES WERE RUSTY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT REPORTS THAT UNINTENTIONALLY PUNCTURED HER FINGER SUPERFICIALLY, BUT NOW IT'S VERY SWOLLEN AND RED. SHE SAYS THAT SHE WAS PREPARING THE OZONE GAS, WHEN REMOVING THE SEAL SHE GOT THE NEEDLE STICK UNINTENTIONALLY, IT WAS A NEEDLE STICK RIGHT IN THE FIRST PHALANX. AT THAT TIME SHE DIDN'T CARE, BUT DURING THE NIGHT OF 3/02 TO 3/03 SHE FELT TOO MUCH PAIN. SINCE SHE IS A NURSE, SHE SELF-MEDICATED WITH AN ANTI-INFLAMMATORY (NIMESULIDA), BUT HASN'T GONE TO SEE A DOCTOR DUE TO COVID-19. IT WAS POSSIBLE TO OBSERVE THE PRESENCE OF EPOXY ON NEEDLE. ___ SINCE THE DAY OF THE CALL, THE PATIENT'S CONDITION HAS NOT EVOLVED TO SEEK MEDICAL ATTENTION. ON THE DAY OF THE EVENT, IT HURT AND BLEED A LITTLE. AFTER BLOOD CLOTTING, SHE WAS ONLY BURNING AND ANNOYING WHEN SHE PUT ON HER GLOVES. DURING THE DAWN OF THE 2ND TO THE 3RD, HER FINGER GOT MUCH WORSE, SHOWING ALL THE SIGNS OF INFLAMMATION (PAIN, HEAT, REDNESS, THROBBING AND EDEMA FOLLOWED BY JOINT STIFFNESS. ON 03/03, SHE STARTED WITH NISULID EVERY 12 HOURS (STILL IN USE). AFTER STARTING THE MEDICATION, SHE HAD A GOOD IMPROVEMENT IN PAIN AND EDEMA, WHICH LIMITED HER MOVEMENTS. ON 3/5, SHE IS LOOKING BETTER, BUT NOT FULLY RECOVERED, SO SHE WILL KEEP THE MEDICATION UNTIL FULL RECOVERY. SHE PERFORMED AN OZONE APPLICATION FOR INFLAMMATORY PURPOSES, FOLLOWED BY LASER THERAPY FOR INFLAMMATION. SHE DOES NOT KNOW HOW TO INFORM THE EXACT AMOUNT AFFECTED EACH DAY, SINCE SHE ONLY DECIDED TO OPEN A COMPLAINT FOR THE FACT THAT OCCURRED WITH HER FINGER. IN HER DAILY ROUTINE, SHE HAS NO WAY OF COUNTING HOW MANY NEEDLES SHE THROWS IN THE TRASH. SHE CAN ONLY GIVE A BASIS FOR THE AMOUNT OF NEEDLES SHE BUYS MONTHLY: SHE BOUGHT 4 TO 5 BOXES, SO THAT THERE IS ALWAYS A SPARE BOX IN STOCK. IN JANUARY OF THIS YEAR HE USED ALL THE BOXES AND STILL HAD TO BUY TWO MORE BECAUSE HE DIDN'T HAVE ENOUGH NEEDLE. IN FEBRUARY, PRACTICALLY THE SAME THING HAPPENED. HOWEVER, HE LEFT THE LAST BOX OF BATCH 0182656 WITH 60 UNUSED UNITS AND BOUGHT ANOTHER BRAND TO CONTINUE THE CARE AFTER THE INCIDENT ON 02/03. SHE FURTHER REPORTS THAT FEELS DIFFICULTIES TO USE IN HER PATIENTS, WASTING DOZENS OF NEEDLES BECAUSE THEY GET UNCOMFORTABLE TO APPLICATION. ADDITIONALLY, SHE IDENTIFIED NEEDLES RUSTY, WHICH IT'S MORE OFTEN IN BATCH 0182656, PURCHASED IN JANUARY AND USED IN FEBRUARY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE PRECISIONGLIDE 30X1/2IN HAD EPOXY ON THE NEEDLE. IT WAS DISCOVERED ON 300 OCCASIONS THAT THE NEEDLES WERE RUSTY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT REPORTS THAT UNINTENTIONALLY PUNCTURED HER FINGER SUPERFICIALLY, BUT NOW IT'S VERY SWOLLEN AND RED. SHE TELLS THAT SHE WAS PREPARING THE OZONE GAS, WHEN REMOVING THE SEAL SHE GOT THE NEEDLE STICK UNINTENTIONALLY, IT WAS A NEEDLE STICK RIGHT IN THE FIRST PHALANX. AT THAT TIME SHE DIDN'T CARE, BUT DURING THE NIGHT OF (B)(6) SHE FELT TOO MUCH PAIN. SINCE SHE IS A NURSE, SHE SELF-MEDICATED WITH AN ANTI-INFLAMMATORY (NIMESULIDA), BUT HASN'T GONE TO SEE A DOCTOR DUE TO COVID-19. IT WAS POSSIBLE TO OBSERVE THE PRESENCE OF EPOXY ON NEEDLE. SINCE THE DAY OF THE CALL, THE PATIENT'S CONDITION HAS NOT EVOLVED TO SEEK MEDICAL ATTENTION. ON THE DAY OF THE EVENT, IT HURT AND BLEED A LITTLE. AFTER BLOOD CLOTTING, SHE WAS ONLY BURNING AND ANNOYING WHEN SHE PUT ON HER GLOVES. DURING THE DAWN OF THE 2ND TO THE 3RD, HER FINGER GOT MUCH WORSE, SHOWING ALL THE SIGNS OF INFLAMMATION (PAIN, HEAT, REDNESS, THROBBING AND EDEMA FOLLOWED BY JOINT STIFFNESS. ON (B)(6) , SHE STARTED WITH NISULID EVERY 12 HOURS (STILL IN USE). AFTER STARTING THE MEDICATION, SHE HAD A GOOD IMPROVEMENT IN PAIN AND EDEMA, WHICH LIMITED HER MOVEMENTS. ON (B)(6) , SHE IS LOOKING BETTER, BUT NOT FULLY RECOVERED, SO SHE WILL KEEP THE MEDICATION UNTIL FULL RECOVERY. SHE PERFORMED AN OZONE APPLICATION FOR INFLAMMATORY PURPOSES, FOLLOWED BY LASER THERAPY FOR INFLAMMATION. SHE DOES NOT KNOW HOW TO INFORM THE EXACT AMOUNT AFFECTED EACH DAY, SINCE SHE ONLY DECIDED TO OPEN A COMPLAINT FOR THE FACT THAT OCCURRED WITH HER FINGER. IN HER DAILY ROUTINE, SHE HAS NO WAY OF COUNTING HOW MANY NEEDLES SHE THROWS IN THE TRASH. SHE CAN ONLY GIVE A BASIS FOR THE AMOUNT OF NEEDLES SHE BUYS MONTHLY: SHE BOUGHT 4 TO 5 BOXES, SO THAT THERE IS ALWAYS A SPARE BOX IN STOCK. IN JANUARY OF THIS YEAR HE USED ALL THE BOXES AND STILL HAD TO BUY TWO MORE BECAUSE HE DIDN'T HAVE ENOUGH NEEDLE. IN FEBRUARY, PRACTICALLY THE SAME THING HAPPENED. HOWEVER, HE LEFT THE LAST BOX OF BATCH 0182656 WITH 60 UNUSED UNITS AND BOUGHT ANOTHER BRAND TO CONTINUE THE CARE AFTER THE INCIDENT ON 02/03. SHE FURTHER REPORTS THAT FEELS DIFFICULTIES TO USE IN HER PATIENTS, WASTING DOZENS OF NEEDLES BECAUSE THEY GET UNCOMFORTABLE TO APPLICATION. ADDITIONALLY, SHE IDENTIFIED NEEDLES RUSTY, WHICH IT'S MORE OFTEN IN BATCH 0182656, PURCHASED IN (B)(6) AND USED IN (B)(6) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481018 NEEDLE PRECISIONGLIDE 30X1/2IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 0182656

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR