BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN

    MDR report key: 10536561 · Received September 15, 2020

    Report

    Report Number
    1917413-2020-00820
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 2, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    K891407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER ADDRESS: (B)(6). E.1. INITIAL REPORTER CITY: (B)(6). E.1. INITIAL REPORTER ZIP: (B)(6). H.6. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED FROM THE CUSTOMER FACILITY FOR EVALUATION. FOUR (4) PHOTOS WERE RETURNED FROM THE CUSTOMER. THE RETURNED PHOTOS SHOW THE CUSTOMER¿S FAILURE MODE OF ¿GLASS BREAKAGE¿. UPON EVALUATION OF THE CUSTOMER RETURNED PHOTOS, THE CUSTOMER¿S PRODUCT ISSUE WAS OBSERVED. THE GLASS IS BROKEN. IN THE FORMING PROCESS, IF THE GLASS IS DAMAGED PRIOR OR QUALITY OF THE GLASS CANE IS POOR, MICROSCOPIC CRACKS CAN OCCUR AND THUS BREAKAGE HAPPENS. INVESTIGATION WAS LIMITED AS NO SAMPLES WERE RECEIVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBES ARE BREAKING DURING CENTRIFUGE WITH A BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN. THIS OCCURRED ON 4 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES ARE BREAKING IN THE CENTRIFUGE. 4 OF 6 OF THE TUBES HAVE BROKEN OR CRACKED IN THE CENTRIFUGE. WE DID NOT HAVE ONE SINGLE TUBE CRACK WITH THE OCT EXPIRATION DATE BATCH WE HAD PREVIOUSLY. ADDITIONALLY, ON (B)(6) 2020 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THEY HAD NO TROUBLE WITH THE PREVIOUS LOT OF CPT TUBES (REF # (B)(4) LOT #9277575 EXP 31-OCT-2020). HOWEVER, ONCE THEY MOVED TO THE NEW BATCH (REF # (B)(4) LOT #0042161 EXP 28-FEB-2021) THEY HAVE 6 TUBES TO BREAK IN THE CENTRIFUGE (FRIDAY 4 OUT 6 BROKE AND TODAY THEY HAD 2 ADDITIONAL TUBES TO BREAK). I VERIFIED THAT WHEN THE TUBES WERE RECEIVED AND INSPECTED THERE WERE NO VISIBLE CRACKS OR DAMAGE DURING SHIPMENT, THE TUBES WERE NOT DROPPED PRIOR TO OR AFTER BLOOD COLLECTION AND THE PROCESSING OF THE TUBES HAS NOT CHANGED SINCE THE NEW LOT WAS PUT INTO USE. (CENTRIFUGATION: 20 MINUTES, 3.3 RPM/1.7 RCF AT ROOM TEMPERATURE IN A SWING BUCKET CENTRIFUGE).

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED. (B)(6) WAS USED AS A PLACE HOLDER BASED ON THE USER AREA CODE AND INITIAL REPORTER FACILITY. 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 TUBES ARE BREAKING DURING CENTRIFUGE WITH A BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN. THIS OCCURRED ON 4 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES ARE BREAKING IN THE CENTRIFUGE. 4 OF 6 OF THE TUBES HAVE BROKEN OR CRACKED IN THE CENTRIFUGE. WE DID NOT HAVE ONE SINGLE TUBE CRACK WITH THE OCT EXPIRATION DATE BATCH WE HAD PREVIOUSLY. ADDITIONALLY, ON 2020-08-31 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THEY HAD NO TROUBLE WITH THE PREVIOUS LOT OF CPT TUBES (REF #362753 LOT #9277575 EXP 31-OCT-2020). HOWEVER, ONCE THEY MOVED TO THE NEW BATCH (REF #362753 LOT #0042161 EXP 28-FEB-2021) THEY HAVE 6 TUBES TO BREAK IN THE CENTRIFUGE (FRIDAY 4 OUT 6 BROKE AND TODAY THEY HAD 2 ADDITIONAL TUBES TO BREAK). I VERIFIED THAT WHEN THE TUBES WERE RECEIVED AND INSPECTED THERE WERE NO VISIBLE CRACKS OR DAMAGE DURING SHIPMENT, THE TUBES WERE NOT DROPPED PRIOR TO OR AFTER BLOOD COLLECTION AND THE PROCESSING OF THE TUBES HAS NOT CHANGED SINCE THE NEW LOT WAS PUT INTO USE. (CENTRIFUGATION: 20 MINUTES, 3.3 RPM/1.7 RCF AT ROOM TEMPERATURE IN A SWING BUCKET CENTRIFUGE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999779 BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362753 0042161 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other