BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NESTABLE SHARPS DISPOSAL SYSTEMS

    MDR report key: 17776564 · Received September 19, 2023

    Report

    Report Number
    2243072-2023-01675
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    September 4, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE PICTURES WERE RECEIVED AS EVIDENCE OF THE REPORTED ISSUE AND VERIFIED. ACCORDING TO THE DEVICE HISTORY RECORD REVIEW, DURING THE MANUFACTURING PROCESS NO ISSUES WERE REPORTED FOR DAMAGED OR BROKEN LIDS FOR THE LOT NUMBERS REPORTED UNDER THIS COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULTS EXHIBIT NO ISSUE REPORTED FOR THE SAME PART NUMBER AND ISSUE THROUGHOUT THE LAST TWELVE MONTHS. BASED ON THIS INVESTIGATION AND LOT NUMBERS PROVIDED, WE ARE ABLE TO CONFIRM THAT THESE PRODUCTS WERE MANUFACTURED BY FLEX ON MAY 22 AND NOVEMBER 23 OF 2023. WITHIN GLOBAL COMPLAINT REPORT, CUSTOMER MENTIONS BROKEN SHARPS CONTAINER LIDS ON ARRIVAL, HOWEVER, NO ADDITIONAL INFORMATION LIKE PICTURE OF THE DAMAGED PRODUCT OR ORIGINAL PACKAGE WAS RECEIVED. ACCORDING WITH THIS INVESTIGATION, IT WAS NOTICED THAT THIS ISSUE AROSE FROM A PRODUCT SOLD IN AUSTRALIA AND ALL THE SHIPPING AND TRANSPORTATION PROCESS FOR ASIA PACIFIC PRODUCTS INDICATES THAT FLEX IS IN CHARGE OF MANUFACTURING, PACKAGING AND LOADING OF THE PRODUCT, WHILE BD IS IN CONTROL OF TRANSPORTATION, TRANSSHIPMENT, DISTRIBUTION AND FINAL DELIVERY. FOR THIS REASON, IT CAN BE CONCLUDED THAT PRODUCTS SOLD OUT OF USA GOES THROUGH DIFFERENT DISTRIBUTION STAGES WHERE THIS KIND OF ISSUE MAY BE GENERATED DUE TO HANDLING CARRIED OUT DURING THE TRANSPORTATION AND THOSE ACTIVITIES ARE OUT OF FLEX¿S REACH. CONSIDERING THAT FAILURE MODE IS RELATED TO BROKEN PARTS, THE MOLD WAS VERIFIED TO RULE OUT THAT THE ISSUE COULD BE GENERATED BY A DAMAGED ON THE MOLD, THE ASSESSMENT CONFIRMS THAT MOLD WAS FREE OF DAMAGES. BASED ON THAT ASSESSMENT, IT CAN BE CONFIRMED THAT THE ISSUE COULD BE GENERATED BY SEVERAL VARIABLES LIKE HIT, INCORRECT HANDLING, INCORRECT STORAGE OR NON-SUITABLE PACKAGING DURING PARTIAL SELLS. AS PART OF THIS INVESTIGATION, A REVIEW OF CUSTOMER COMPLAINT RECORDS WAS PERFORMED; ACCORDING TO THE CC¿S RECORDS, ONE ADDITIONAL COMPLAINT WAS RECEIVED THROUGH THE LAST TWELVE MONTHS FOR THE SAME PART NUMBER AND ISSUE. THIS PREVIOUS COMPLAINT WAS CLOSED AS INCOMPLETE SINCE THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD BE PERFORMED ON BASIS OF PHOTO REPRESENTATION, AND A ROOT CAUSE COULD BE DETERMINED AS POTENTIAL ROOT CAUSE AS BELOW: ¿ PRODUCT DAMAGED DURING THE TRANSSHIPPED PROCESS MADE BY BD¿S SECOND PROVIDER. ¿ NON-CONTROLLED METHOD TO SHIP PARTIAL BOXES TO END USER. ¿ PRODUCT DAMAGED DURING THE SHIPMENT OR DISTRIBUTION. ¿ INCORRECT REPACKAGING AT THE TIME TO PERFORM PARTIAL SALES. BASED ON INFORMATION PROVIDED IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE LIKE A FAILURE MODE RELATED TO THE MANUFACTURING PROCESS BECAUSE THERE WAS NOT ENOUGH INFORMATION LIKE METHOD USED TO HANDLE, SHIPPED PARTIAL SELLS AND CONTROLS TO STORAGE THE REMAINING PRODUCT WITHIN DISTRIBUTOR FACILITY. THE CONTROLS WERE VERIFIED WITHIN THE MANUFACTURING PROCESS AND CONFIRMED AS CAPABLE TO DETECT BROKEN OR DAMAGED LIDS.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1., AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE EXPIRATION DATE: NA. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2329981, D4. MEDICAL DEVICE EXPIRATION DATE: NA, H4. DEVICE MANUFACTURE DATE:05 DEC 2022. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ NESTABLE SHARPS DISPOSAL SYSTEMS THE LID WAS DAMAGED. THIS OCCURRED 12 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN SHARPS CONTAINER LIDS ON ARRIVAL. PLEASE SEE ATTACHED WORD DOCUMENT WITH DETAILS. DEFECT FOR CAT#300740: LOT 2329981 - (B)(4) UNITS. LOT 2142950 - (B)(4) UNITS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ NESTABLE SHARPS DISPOSAL SYSTEMS THE LID WAS DAMAGED. THIS OCCURRED 12 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN SHARPS CONTAINER LIDS ON ARRIVAL. PLEASE SEE ATTACHED WORD DOCUMENT WITH DETAILS. DEFECT FOR CAT#300740: LOT 2329981: (B)(4) UNITS. LOT 2142950: (B)(4) UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062256 BD¿ NESTABLE SHARPS DISPOSAL SYSTEMS HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 2142950

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown