BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INJECTOR N35-O¿

    MDR report key: 8647124 · Received May 28, 2019

    Report

    Report Number
    3003152976-2019-00350
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 10, 2019
    Report Date
    July 2, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K181221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.1 MEDICAL DEVICE TYPE: ONB. D.2. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. G.5. PMA / 510(K)#: K181221.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH ADDITIONAL INFORMATION THAT WAS RECEIVED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THERE WERE FLOW ISSUES (PUSH AND PULL FORCE DURING "EXTRACTION" NOT EASY) WITH A BD INJECTOR N35-O¿. THIS OCCURRED ON 7 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052 BATCH NO: 1807712. (2 OF 5) IT WAS REPORTED THAT ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW DIFFICULT IT IS TO EXTRACT THE DRUG FROM VIALS AND PUSH INTO IV BAG. EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "PUSH AND PULL FORCE DURING EXTRACTION IS NOT EASY (X7 INCIDENTS): ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW IT IS TO EXTRACT DRUG FROM VIALS AND PUSH INTO IV BAG. TECHS ARE USED TO EXTRACTING WITH EASE SINCE THEY USED 16 GAUGE NEEDLE, THEY NOTICED THE DIFFERENCE WITH PHASEAL SINCE THEY ARE USING FOR CISPLATIN. N35-O LOT NUMBER 1807712."

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1807712, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS. ALL UNITS FROM LOT 1807712 WERE INSPECTED WITH NO DEFECTS OBSERVED. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE SAMPLES WERE FUNCTIONALLY TESTED AND IN ALL CASES, FLOW WAS OBSERVED AND THE PRODUCT FUNCTIONED AS INTENDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE FLOW ISSUES (PUSH AND PULL FORCE DURING EXTRACTION NOT EASY) WITH A BD INJECTOR N35-O¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052 BATCH NO: 1807712. (2 OF 5) IT WAS REPORTED THAT ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW DIFFICULT IT IS TO EXTRACT THE DRUG FROM VIALS AND PUSH INTO IV BAG. EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "PUSH AND PULL FORCE DURING EXTRACTION IS NOT EASY (X7 INCIDENTS): ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW IT IS TO EXTRACT DRUG FROM VIALS AND PUSH INTO IV BAG. TECHS ARE USED TO EXTRACTING WITH EASE SINCE THEY USED 16 GAUGE NEEDLE, THEY NOTICED THE DIFFERENCE WITH PHASEAL SINCE THEY ARE USING FOR CISPLATIN. N35-O LOT NUMBER 1807712."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE FLOW ISSUES (PUSH AND PULL FORCE DURING "EXTRACTION" NOT EASY) WITH A BD INJECTOR N35-O¿. THIS OCCURRED ON 7 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052 BATCH NO: 1807712. (2 OF 5) IT WAS REPORTED THAT ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW DIFFICULT IT IS TO EXTRACT THE DRUG FROM VIALS AND PUSH INTO IV BAG. EVENT DESCRIPTION PER EMAIL STATES, "PUSH AND PULL FORCE DURING EXTRACTION IS NOT EASY (X7 INCIDENTS): ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW IT IS TO EXTRACT DRUG FROM VIALS AND PUSH INTO IV BAG. TECHS ARE USED TO EXTRACTING WITH EASE SINCE THEY USED 16 GAUGE NEEDLE, THEY NOTICED THE DIFFERENCE WITH PHASEAL SINCE THEY ARE USING FOR CISPLATIN. N35-O LOT NUMBER 1807712."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE FLOW ISSUES (PUSH AND PULL FORCE DURING EXTACTION NOT EASY) WITH A BD INJECTOR N35-O¿. THIS OCCURRED ON 7 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052 BATCH NO: 1807712. (2 OF 5). IT WAS REPORTED THAT ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW DIFFICULT IT IS TO EXTRACT THE DRUG FROM VIALS AND PUSH INTO IV BAG. EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "PUSH AND PULL FORCE DURING EXTRACTION IS NOT EASY (X7 INCIDENTS): ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW IT IS TO EXTRACT DRUG FROM VIALS AND PUSH INTO IV BAG. TECHS ARE USED TO EXTRACTING WITH EASE SINCE THEY USED 16 GAUGE NEEDLE, THEY NOTICED THE DIFFERENCE WITH PHASEAL SINCE THEY ARE USING FOR CISPLATIN. N35-O LOT NUMBER 1807712.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE FLOW ISSUES (PUSH AND PULL FORCE DURING EXTRACTION NOT EASY) WITH A BD INJECTOR N35-O¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 515052, BATCH NO: 1807712. (2 OF 5). IT WAS REPORTED THAT ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW DIFFICULT IT IS TO EXTRACT THE DRUG FROM VIALS AND PUSH INTO IV BAG. EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "PUSH AND PULL FORCE DURING EXTRACTION IS NOT EASY (X7 INCIDENTS): ALL TECHS THAT MIXED THIS WEEK STRUGGLED AND COMPLAINED ABOUT HOW IT IS TO EXTRACT DRUG FROM VIALS AND PUSH INTO IV BAG. TECHS ARE USED TO EXTRACTING WITH EASE SINCE THEY USED 16 GAUGE NEEDLE, THEY NOTICED THE DIFFERENCE WITH PHASEAL SINCE THEY ARE USING FOR CISPLATIN. N35-O LOT NUMBER 1807712."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437982 BD INJECTOR N35-O¿ INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 1807712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other