BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR

    MDR report key: 10907463 · Received November 26, 2020

    Report

    Report Number
    3003916417-2020-00346
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    November 4, 2020
    Report Date
    December 15, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    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

    H.6. INVESTIGATION: BD DID NOT RECEIVE SAMPLES OR PHOTOS FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD IS REVIEWING SPECIFIC AREAS IN THE MANUFACTURING PROCESS RELATING TO THIS ISSUE. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPERS ARE POPPING OFF WITH BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR. THERE WERE 3 OCCASIONS THAT THEY POPPED OFF DURING TRANSPORT, 1 WHERE THE STOPPER POPPED OFF IN COLLECTORS LAB COAT POCKET, AS WELL WITH 4 OTHER TUBES, AFTER COLLECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: IT WAS REPORTED THAT STOPPERS POPPED OFF FROM 3 TUBES THAT OPEN COLLECTION TECHNIQUE WAS PERFORMED, AT THAT TIME THE CATALOG AND BATCH OF THOSE 3 TUBES WERE NOT AVAILABLE (IT WAS ONLY REPORTED THAT THEY REGARD TO THE GEL TUBES). AND IT WAS REPORTED THE OPENING (STOPPER POP OFF) OF 1 TUBE WHERE THE TECHNIQUE WAS THROUGH THE VACUUM, AND THE COLLECTOR PUT THE TUBE INTO HER COAT'S POCKET AFTER COLLECTING THE SAMPLE, AND WHEN SHE GOT DOWN SHE NOTICED THAT THE TUBE OPENED (THE STOPPER POPPED OFF) AND TURNED HER CLOTHES DIRTY. THE TUBE HAS NOT BEEN OPENED, SHE ASSURES THAT THE BLOOD COLLECTION WAS MADE THROUGH THE VACUUM, THIS TUBE IS THE NATIONAL GEL 3.5ML (360059). EVENTUALLY, OTHER UNITS ARE ALSO COMING WITH THE STOPPER OUT FROM THE PARDINI WHERE THE SAMPLES ARE COLLECTED, BUT THOSE THE RESPONSIBLE WAS NOT ABLE TO SPECIFY THE COLLECTION TECHNIQUE AND THE TUBES' INFORMATION, ONLY REPORTS THAT THEY ARE THE GEL TUBES. FURTHERMORE, SHE REPORTS THAT THE GEL TUBES, WHEN COMPARED TO OTHER BD TUBES THAT THE CUSTOMER USES, HAVE THE VACUUM SO SLOW THAT HAS MADE THE COLLECTIONS TAKE TOO LONG. SHE HAS BEEN NOTICING IT ONLY IN GEL TUBES, BUT CANNOT SPECIFY TO WHICH WOULD THE MATERIAL # BE WHERE THE TUBES ARE PRESENTING SLOWNESS, SINCE CUSTOMER USES BOTH 3.5 ML ALSO 5ML (COMPLAINT #). EVENT #1: PRODUCTS INFORMATION (MATERIAL# AND BATCH #); R: 360059, BATCH 0060337; AT WHAT MOMENT DID THE STOPPERS POP OFF? (DURING CENTRIFUGE, DURING TRANSPORTATION, ETC.)? R: DURING TRANSPORTATION; IF THE STOPPERS POPPED OFF IN CENTRIFUGE, WHAT WAS THE CENTRIFUGE SPEED? FOR HOW LONG WERE THE TUBES LEFT IN CENTRIFUGE? IS THE CENTRIFUGE'S BUCKET OF FIXED ANGLE OR SWING? HOW DO THE TUBES FIT INTO THE SUPPORT (COMPLETELY INSIDE OF IT, OR ARE THEY SUSPENDED BY THE STOPPERS?) R: N/A. ARE THERE SAMPLES AVAILABLE FOR EVALUATION? R: NO. EVENT #2: IS THIS TUBE AVAILABLE FOR EVALUATION? R: NO. EVENT #3: HOW MANY UNITS HAVE BEEN AFFECTED? R: 3 OR 4; PRODUCTS INFORMATION (MATERIAL# AND BATCH#); R: 360059, BATCH 0060337; ARE THE TUBES TRANSPORTED ON HORIZONTAL OR VERTICAL POSITION? R: VERTICAL POSITION; IS IT POSSIBLE TO FIND OUT THE BLOOD COLLECTION TECHNIQUE USED IN FACILITY? R: BOTH TECHNIQUES: OPEN AND CLOSED; ARE THERE SAMPLES AVAILABLE FOR EVALUATION? R: NO.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPERS ARE POPPING OFF WITH BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR. THERE WERE 3 OCCASIONS THAT THEY POPPED OFF DURING TRANSPORT, 1 WHERE THE STOPPER POPPED OFF IN COLLECTORS LAB COAT POCKET, AS WELL WITH 4 OTHER TUBES, AFTER COLLECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: IT WAS REPORTED THAT STOPPERS POPPED OFF FROM 3 TUBES THAT OPEN COLLECTION TECHNIQUE WAS PERFORMED, AT THAT TIME THE CATALOG AND BATCH OF THOSE 3 TUBES WERE NOT AVAILABLE (IT WAS ONLY REPORTED THAT THEY REGARD TO THE GEL TUBES). AND IT WAS REPORTED THE OPENING (STOPPER POP OFF) OF 1 TUBE WHERE THE TECHNIQUE WAS THROUGH THE VACUUM, AND THE COLLECTOR PUT THE TUBE INTO HER COAT'S POCKET AFTER COLLECTING THE SAMPLE, AND WHEN SHE GOT DOWN SHE NOTICED THAT THE TUBE OPENED (THE STOPPER POPPED OFF) AND TURNED HER CLOTHES DIRTY. THE TUBE HAS NOT BEEN OPENED, SHE ASSURES THAT THE BLOOD COLLECTION WAS MADE THROUGH THE VACUUM, THIS TUBE IS THE NATIONAL GEL 3.5ML (360059). EVENTUALLY, OTHER UNITS ARE ALSO COMING WITH THE STOPPER OUT FROM THE PARDINI WHERE THE SAMPLES ARE COLLECTED, BUT THOSE THE RESPONSIBLE WAS NOT ABLE TO SPECIFY THE COLLECTION TECHNIQUE AND THE TUBES' INFORMATION, ONLY REPORTS THAT THEY ARE THE GEL TUBES. FURTHERMORE, SHE REPORTS THAT THE GEL TUBES, WHEN COMPARED TO OTHER BD TUBES THAT THE CUSTOMER USES, HAVE THE VACUUM SO SLOW THAT HAS MADE THE COLLECTIONS TAKE TOO LONG. SHE HAS BEEN NOTICING IT ONLY IN GEL TUBES, BUT CANNOT SPECIFY TO WHICH WOULD THE MATERIAL # BE WHERE THE TUBES ARE PRESENTING SLOWNESS, SINCE CUSTOMER USES BOTH 3.5 ML ALSO 5ML (COMPLAINT #). EVENT #1: PRODUCTS INFORMATION (MATERIAL # AND BATCH #); R: 360059, BATCH 0060337; AT WHAT MOMENT DID THE STOPPERS POP OFF? (DURING CENTRIFUGE, DURING TRANSPORTATION, ETC.)? R: DURING TRANSPORTATION; -IF THE STOPPERS POPPED OFF IN CENTRIFUGE, WHAT WAS THE CENTRIFUGE SPEED? FOR HOW LONG WERE THE TUBES LEFT IN CENTRIFUGE? IS THE CENTRIFUGE'S BUCKET OF FIXED ANGLE OR SWING? HOW DO THE TUBES FIT INTO THE SUPPORT (COMPLETELY INSIDE OF IT, OR ARE THEY SUSPENDED BY THE STOPPERS?) R: N/A. ARE THERE SAMPLES AVAILABLE FOR EVALUATION? R: NO. EVENT #2: IS THIS TUBE AVAILABLE FOR EVALUATION? R: NO. EVENT #3: HOW MANY UNITS HAVE BEEN AFFECTED? R: 3 OR 4; PRODUCTS INFORMATION (MATERIAL # AND BATCH #); R: 360059, BATCH 0060337; ARE THE TUBES TRANSPORTED ON HORIZONTAL OR VERTICAL POSITION? R: VERTICAL POSITION; IS IT POSSIBLE TO FIND OUT THE BLOOD COLLECTION TECHNIQUE USED IN FACILITY? R: BOTH TECHNIQUES: OPEN AND CLOSED; ARE THERE SAMPLES AVAILABLE FOR EVALUATION? R: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377685 BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 0060337

    Patients

    Seq Age Sex Outcome Treatment
    1