BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 6910897 · Received October 3, 2017

    Report

    Report Number
    3003152976-2017-00056
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 14, 2017
    Report Date
    November 1, 2017
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO USED SAMPLES OF 50LL WITHOUT BLISTER, ONE B.BRAUN NON-VENTED DISPENSING PIN AND ONE NACL BAG WITH OTHER B.BRAUN NON-VENTED DISPENSING PIN CONNECTED HAVE BEEN RECEIVED. IT HAS ALSO BEEN RECEIVED 4 PICTURES. ON VISUAL INSPECTION OF THE TWO SYRINGES AND 4 PICTURES, IT CAN BE OBSERVED BOTH ARE FILLED WITH NACL BUT ONE OF THEM THE LIQUID INSIDE THE SYRINGE IS BLUE. NO BLUE COLOR CAN BE OBSERVED INSIDE THE NACL BAG. THE NACL BAG HAS A BLUE CONNECTION. TEN RETAINED SAMPLES OF 50LL LOT 1706236P ARE EVALUATED. ON VISUAL INSPECTION OF THESE TEN RETAINED SAMPLES NO DEFECT NOR FOREIGN MATTER CAN BE OBSERVED IN ANY OF THEM. DHR OF LOT 1706236P HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. DURING MANUFACTURING PROCESS, FINAL PRODUCTS ARE SAMPLED AND SUBJECTED TO VISUAL INSPECTIONS ACCORDING TO PROCEDURES. SAMPLE RECEIVED WITH BLUE COLOR INSIDE IS EMPTY AND OBSERVED IN THE MICROSCOPE. NO FOREIGN MATTER OR DEFECT CAN BE OBSERVED IN THE STOPPER OR IN THE BARREL THAT COULD HAVE CAUSED THIS DEFECT. THIS SYRINGE IS FILLED AGAIN FROM THE NACL BAG RECEIVED THROUGH B.BRAUN NON-VENTED DISPENSING PIN NOT OBSERVING ANY BLUE COLOR WHEN SOLUTION IS INSIDE THE SYRINGE. THE TWO B.BRAUN NON-VENTED DISPENSING PINS RECEIVED ARE INTRODUCED INSIDE A VASE WITH NACL FROM THE BAG RECEIVED, NOT OBSERVING ANY DISCOLORATION FROM THE BLUE COMPONENT OF THE PINS AND NO BLUE COLOR IN THE VASE. THE SAME TEST IS DONE WITH ALCOHOL 70%, OBTAINING THE SAME RESULT. THE TEN RETAINED SAMPLES OF LOT 1706236P ARE FILLED WITH THE NACL FROM THE BAG, NOT OBSERVING ANY REACTION OR BLUE COLOR INSIDE THE SYRINGES. ACCORDING TO THESE TESTS, WE CANNOT REPRODUCE THIS DEFECT AND NO MANUFACTURING DEFECT HAS BEEN FOUND IN THE SYRINGE RECEIVED OR IN THE RETAINED SAMPLES THAT COULD HAVE CAUSED THIS DEFECT. INVESTIGATION CONCLUSION: DEFECT: SODIUM CHLORIDE TURNS BLUE INSIDE THE SYRINGE (MISCELLANEOUS). TWO USED SAMPLES OF 50LL WITHOUT BLISTER, ONE B.BRAUN NON-VENTED DISPENSING PIN AND ONE NACL BAG WITH OTHER B.BRAUN NON-VENTED DISPENSING PIN CONNECTED HAVE BEEN RECEIVED. IT HAS ALSO BEEN RECEIVED 4 PICTURES. ON VISUAL INSPECTION OF THE TWO SYRINGES AND 4 PICTURES, IT CAN BE OBSERVED BOTH ARE FILLED WITH NACL BUT ONE OF THEM THE LIQUID INSIDE THE SYRINGE IS BLUE. NO BLUE COLOR CAN BE OBSERVED INSIDE THE NACL BAG. THE NACL BAG HAS A BLUE CONNECTION. TEN RETAINED SAMPLES OF 50LL LOT 1706236P ARE EVALUATED. ON VISUAL INSPECTION OF THESE TEN RETAINED SAMPLES NO DEFECT NOR FOREIGN MATTER CAN BE OBSERVED IN ANY OF THEM. (SEE ATTACHED PICTURES). DHR OF LOT 1706236P HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. DURING MANUFACTURING PROCESS, FINAL PRODUCTS ARE SAMPLED AND SUBJECTED TO VISUAL INSPECTIONS ACCORDING TO PROCEDURES (JG-301, JG-302, JG-303 AND JG-304). PROCESS: VISUAL INSPECTION: PRINTING 30 SAMPLES PER HOUR, AFTER ANY INTERVENTION IN THE EQUIPMENT OR ONCE AT THE BEGINNING OF THE SHIFT. ASSEMBLY: 30 SAMPLES PER HOUR, AFTER ANY INTERVENTION IN THE EQUIPMENT OR ONCE AT THE BEGINNING OF THE SHIFT. PACKING 1 STEP PER HOUR, AFTER ANY INTERVENTION IN THE EQUIPMENT, AFTER A STOP OF MORE THAN 1 HOUR, ONCE AT THE BEGINNING OF THE SHIFT, WHEN FILM OR PAPER ROLLER ARE CHANGED, AFTER MAINTENANCE. PACKAGING: 1 SHELF-PACKAGE PER PALLET. SAMPLE RECEIVED WITH BLUE COLOR INSIDE IS EMPTY AND OBSERVED IN THE MICROSCOPE. NO FOREIGN MATTER OR DEFECT CAN BE OBSERVED IN THE STOPPER OR IN THE BARREL THAT COULD HAVE CAUSED THIS DEFECT. THIS SYRINGE IS FILLED AGAIN FROM THE NACL BAG RECEIVED THROUGH B.BRAUN NON-VENTED DISPENSING PIN NOT OBSERVING ANY BLUE COLOR WHEN SOLUTION IS INSIDE THE SYRINGE. THE TWO B.BRAUN NON-VENTED DISPENSING PINS RECEIVED ARE INTRODUCED INSIDE A VASE WITH NACL FROM THE BAG RECEIVED, NOT OBSERVING ANY DISCOLORATION FROM THE BLUE COMPONENT OF THE PINS AND NO BLUE COLOR IN THE VASE. THE SAME TEST IS DONE WITH ALCOHOL 70%, OBTAINING THE SAME RESULT. THE TEN RETAINED SAMPLES OF LOT 1706236P ARE FILLED WITH THE NACL FROM THE BAG, NOT OBSERVING ANY REACTION OR BLUE COLOR INSIDE THE SYRINGES. (SEE ATTACHED PICTURES). ACCORDING TO THESE TESTS, WE CANNOT REPRODUCE THIS DEFECT AND NO MANUFACTURING DEFECT HAS BEEN FOUND IN THE SYRINGE RECEIVED OR IN THE RETAINED SAMPLES THAT COULD HAVE CAUSED THIS DEFECT. ROOT CAUSE DESCRIPTION: ACCORDING TO THESE TESTS, WE CANNOT REPRODUCE THIS DEFECT AND NO MANUFACTURING DEFECT HAS BEEN FOUND IN THE SYRINGE RECEIVED OR IN THE RETAINED SAMPLES THAT COULD HAVE CAUSED THIS DEFECT.

    Additional Manufacturer Narrative · 1

    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 A BD PLASTIPAK 50ML SYRINGE CONCENTRIC LUER LOCK¿ X 60 WAS FOUND WITH FOREIGN MATTER IN SYRINGE CAUSING A DISCOLORATION OF SOLUTION. THIS WAS OBSERVED DURING USE. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689468 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON, S.A. 1706236P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other