BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 10276928 · Received July 15, 2020

    Report

    Report Number
    1024879-2020-00473
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 22, 2020
    Report Date
    July 29, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/22/2020. H.6. INVESTIGATION: BD RECEIVED 7 SHELF PACKS FROM THE CUSTOMER FOR INVESTIGATION. 30 SAMPLES WERE EVALUATED BY DRAW TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED IN 13 OF THE TUBES TESTED. THE RETURNED TUBES WERE VISUALLY EXAMINED AND ALL COMPONENTS (TUBE AND STOPPER) WERE MADE TO SPECIFICATION WITH NO EVIDENCE OF NON-CONFORMANCE. 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 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBES HAVE NO VACUUM. 4 OF 4: DATE OF EVENT (B)(6) 2022, MALE. THIS COMPLAINT WAS CREATED AS CUSTOMER PRESENTED NEW INFORMATION IN REPLIED INFORMATION REQUEST OF (B)(4). ORIGINAL INFORMATION PRESENTED, - "I RECEIVED A CALL FROM OUR WALNUT STREET PSCS REGARDING SSTS SHE RECEIVED IN HER MOST RECENT ORDER WITH THE LOT NUMBER 0094054 AS STATED BELOW. SHE STATES THE TUBES HAVE NO VACUUM. PLEASE ARRANGE AN EXCHANGE OF THE ITEMS AS SOON AS POSSIBLE, SHE RECEIVED 8 PACKS OF CONV SST 8.5ML." 25-JUN: RCVD AN EMAIL FROM THE CUSTOMER WITH THE FOLLOWING INFORMATION: WAS THERE MULTIPLE PATIENTS INVOLVEMENT? IF SO, PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH INCIDENT: YES MALE AND FEMALE AGES 20S TO 80S. ARE PATIENT IDENTIFIERS AVAILABLE? IF SO, PLEASE PROVIDE A FEW (GENDER, DOB, AGE, WEIGHT, ETC.) NO. WHAT IS THE DATE OF EVENT(S)? (B)(6) 2020 AND (B)(6) 2020. HOW MANY UNITS (TUBES) AFFECTED? HALF A PACK. WHAT IS THE FREQUENCY OR OCCURRENCE RATE (1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY TEST PER DAY ETC.) MULTIPLE PATIENTS, ONE DAY, 2 DIFFERENT PACKS ABOUT HALF A PACK. PER DAY. WHAT IS THE LABELED DRAW VOLUME (2ML, 3MLETC) 8.5 ML. HOW WAS THE TUBE REJECTED (I.E.: AT THE COLLECTION, BY THE LAB, BY AUTOMATED FILL LEVEL SENSING, ETC.)? AT THE COLLECTION. WHAT WAS THE TUBE¿S EXPIRATION DATE? 03/31/2021. HOW WAS THE TUBE DRAWN? FIRST TUBES DRAWN, OR ONLY TUBE NEEDED. WAS A DISCARD TUBE USED? AT FIRST NO, THEN WHEN THE TUBES WOULDN'T FILL UP A DIFFERENT TUBES WERE USED AND THERE WERE NO PROBLEM WITH THE OTHER TUBES. WAS A SUCCESSFUL DRAW ACHIEVED WITH THE SAME LOT? NO. IS THIS HAPPENING WITH ONE PARTICULAR: DEPARTMENT, UNIT, AND SHIFT, TIME OF DAY OR PERSON: WLN PSC, 2 DIFFERENT PHLEBOTOMISTS, LATE AFTERNOON ON FRIDAY AROUND 2:00 PM THEN EARLY MONDAY MORNING, AROUND 07:30 AM. WHAT WAS METHOD OF DRAW? STRAIGHT NEEDLE. IF USING A WINGSET WERE THE FITTING TIGHT/SECURE? (CONNECTION BETWEEN THREADING LUER ADAPTOR TO HOLDER AND MALE TO FEMALE CONNECTION). HAVE THE TUBES BEEN EXPOSED TO EXTREME HEAT: NO. HOW MANY LOCATIONS AFFECTED (IMPATIENT, OUTPATIENTS, ETC.) PSC. ARE UNUSED SAMPLES OF THE AFFECTED BATCH/LOT AVAILABLE FOR INVESTIGATION? IF YES, I WILL PROVIDE YOU A PREPAID SHIPPING LABEL FOR SAMPLE RETURN. YES. SMAX WORK ORDER NOTES: 6/19/2020 1ST ATTEMPT TO CALL THE CUSTOMER. LEFT A VOICEMAIL. 6/25/2020 2ND ATTEMPT TO CONTACT CUSTOMER. SENT AN EMAIL. 7/01/2020 3RD ATTEMPT TO CONTACT CUSTOMER. LEFT A VOICEMAIL. 7/06/2020 NO RESPONSE FROM THE CUSTOMER. 07/07/2020 WO REVIEWED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE TUBES HAVE NO VACUUM. 4 OF 4: DATE OF EVENT (B)(6), MALE THIS COMPLAINT WAS CREATED AS CUSTOMER PRESENTED NEW INFORMATION IN REPLIED INFORMATION REQUEST OF PR (B)(6). ORIGINAL INFORMATION PRESENTED, - "I RECEIVED A CALL FROM OUR WALNUT STREET PSCS REGARDING SSTS SHE RECEIVED IN HER MOST RECENT ORDER WITH THE LOT NUMBER 0094054 AS STATED BELOW. SHE STATES THE TUBES HAVE NO VACUUM. PLEASE ARRANGE AN EXCHANGE OF THE ITEMS AS SOON AS POSSIBLE, SHE RECEIVED 8 PACKS OF CONV SST 8.5 ML." (B)(6): RCVD AN EMAIL FROM THE CUSTOMER WITH THE FOLLOWING INFORMATION: WAS THERE MULTIPLE PATIENTS INVOLVEMENT? IF SO, PLEASE PROVIDE THE FOLLOWING INFORMATION FOR EACH INCIDENT: YES, MALE AND FEMALE AGES 20S TO 80S. ARE PATIENT IDENTIFIERS AVAILABLE? IF SO, PLEASE PROVIDE A FEW (GENDER, DOB, AGE, WEIGHT, ETC.) NO. WHAT IS THE DATE OF EVENT(S)? (B)(6) 2020 AND (B)(6) 2020. HOW MANY UNITS (TUBES) AFFECTED? HALF A PACK. WHAT IS THE FREQUENCY OR OCCURRENCE RATE (1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY TEST PER DAY ETC.) MULTIPLE PATIENTS, ONE DAY, 2 DIFFERENT PACKS ABOUT HALF A PACK PER DAY. WHAT IS THE LABELED DRAW VOLUME (2 ML, 3 ML, ETC.) 8.5 ML. HOW WAS THE TUBE REJECTED (I.E.: AT THE COLLECTION, BY THE LAB, BY AUTOMATED FILL LEVEL SENSING, ETC.)? AT THE COLLECTION. WHAT WAS THE TUBE¿S EXPIRATION DATE? 03/31/2021. HOW WAS THE TUBE DRAWN? FIRST TUBES DRAWN, OR ONLY TUBE NEEDED. WAS A DISCARD TUBE USED? AT FIRST NO, THEN WHEN THE TUBES WOULDN'T FILL UP A DIFFERENT TUBES WERE USED AND THERE WERE NO PROBLEM WITH THE OTHER TUBES. WAS A SUCCESSFUL DRAW ACHIEVED WITH THE SAME LOT? NO. IS THIS HAPPENING WITH ONE PARTICULAR: DEPARTMENT, UNIT, AND SHIFT, TIME OF DAY OR PERSON: WLN PSC, 2 DIFFERENT PHLEBOTOMISTS, LATE AFTERNOON ON FRIDAY AROUND 2:00 PM THEN EARLY MONDAY MORNING, AROUND 07:30 AM. WHAT WAS METHOD OF DRAW? STRAIGHT NEEDLE. IF USING A WINGSET WERE THE FITTING TIGHT/SECURE? (CONNECTION BETWEEN THREADING LUER ADAPTOR TO HOLDER AND MALE TO FEMALE CONNECTION) HAVE THE TUBES BEEN EXPOSED TO EXTREME HEAT: NO. HOW MANY LOCATIONS AFFECTED (IMPATIENT, OUTPATIENTS, ETC.) PSC. ARE UNUSED SAMPLES OF THE AFFECTED BATCH/LOT AVAILABLE FOR INVESTIGATION? IF YES, I WILL PROVIDE YOU A PREPAID SHIPPING LABEL FOR SAMPLE RETURN. YES. SMAX WORK ORDER NOTES: 6/19/2020 1ST ATTEMPT TO CALL THE CUSTOMER. LEFT A VOICEMAIL. 6/25/2020 2ND ATTEMPT TO CONTACT CUSTOMER. SENT AN EMAIL. 7/01/2020 3RD ATTEMPT TO CONTACT CUSTOMER. LEFT A VOICEMAIL. 7/06/2020 NO RESPONSE FROM THE CUSTOMER. 07/07/2020 WO REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739005 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367988 0094054 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other