BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 17986255 · Received October 23, 2023

    Report

    Report Number
    1911916-2023-00798
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 19, 2023
    Report Date
    November 6, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A CLEAR, FOREIGN OBJECT IN A SYRINGE WHEN USING A BLUNT FILL NEEDLE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS TWO PACKAGING BLISTERS. ONE IS A 3ML SYRINGE AND THE OTHER IS AN 18G NEEDLE. NEXT TO THE PACKAGING BLISTERS, THERE IS A SYRINGE WITH A NEEDLE ASSEMBLY. THE SYRINGE HAS A SOLUTION IN IT AND THERE IS AN ARROW POINTING TO THE SYRINGE RUBBER STOPPER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305180, LOT 3181345. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PATIENT PROBLEM CODE: F27 ¿ NO PATIENT INVOLVEMENT. DEVICE PROBLEM CODE: A180104 - DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MAT#: 305180, BATCH#: 3181345. IT WAS REPORTED BY CUSTOMER THAT CUSTOMER FOUND ON AN ASSEMBLY OF A BLUNT FILL NEEDLE 18G X 1.5 TW, BD #305180, LOT #3181345. CUSTOMER NOTICED WHAT APPEARED TO BE A CLEAR, FOREIGN OBJECT IN THE SYRINGE. THE DATE OF THE INCIDENT IS 10.19.2023. THE PRODUCT DID NOT REACH THE PATIENT, NO HARM RESULTED. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE RECEIVED A PRODUCT COMPLAINT FROM THE XXXXX CONCERNING PARTICULATE MATTER FOUND ON AN ASSEMBLY OF A BD 3ML LL TIP SYRINGE, PART #309657, LOT #3173752 AND A BLUNT FILL NEEDLE 18G X 1.5 TW, BD #305180, LOT #3181345. THE DATE OF THE INCIDENT IS 10.19.2023. THE PRODUCT DID NOT REACH THE PATIENT, NO HARM RESULTED. I¿VE INCLUDED AN ATTACHMENT OF THE EMAIL STREAM HERE WHICH ALSO SHOWS A PICTURE OF THE DEVICES. PLEASE HAVE A RMA AND MAILER SENT TO MY ATTENTION AT THE ADDRESS BELOW OR EMAILED. THE COMPLAINT IS DESCRIBED: ¿UPON ASSEMBLY OF NEEDLE AND SYRINGE I NOTICED WHAT APPEARED TO BE A CLEAR, FOREIGN OBJECT IN THE SYRINGE. IT LOOKED LIKE GLASS AND UPON REMOVAL OF THE PLUNGER THERE WAS A HARD, CLEAR SUBSTANCE ON THE PLUNGER. NOTHING HAD BEEN DRAWN INTO THE SYRINGE AT THIS TIME AND BOTH WERE UNUSED AT THIS TIME. R. B. , RN APSM HVC HAS BOTH ITEMS AND THEIR RESPECTIVE PACKAGES AS WELL AS PICTURES OF EACH..¿

    Description of Event or Problem · 0

    MAT#: 305180. BATCH#: 3181345. IT WAS REPORTED BY CUSTOMER THAT CUSTOMER FOUND ON AN ASSEMBLY OF A BLUNT FILL NEEDLE 18G X 1.5 TW, BD #305180, LOT #3181345. CUSTOMER NOTICED WHAT APPEARED TO BE A CLEAR, FOREIGN OBJECT IN THE SYRINGE. THE DATE OF THE INCIDENT IS (B)(6) 2023. THE PRODUCT DID NOT REACH THE PATIENT, NO HARM RESULTED. VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. WE RECEIVED A PRODUCT COMPLAINT FROM THE XXXXX CONCERNING PARTICULATE MATTER FOUND ON AN ASSEMBLY OF A BD 3ML LL TIP SYRINGE, PART #309657, LOT #3173752 AND A BLUNT FILL NEEDLE 18G X 1.5 TW, BD #305180, LOT #3181345. THE DATE OF THE INCIDENT IS (B)(6) 2023. THE PRODUCT DID NOT REACH THE PATIENT, NO HARM RESULTED. PLEASE HAVE A RMA AND MAILER SENT TO MY ATTENTION AT THE ADDRESS BELOW OR EMAILED. THE COMPLAINT IS DESCRIBED: ¿UPON ASSEMBLY OF NEEDLE AND SYRINGE I NOTICED WHAT APPEARED TO BE A CLEAR, FOREIGN OBJECT IN THE SYRINGE. IT LOOKED LIKE GLASS AND UPON REMOVAL OF THE PLUNGER THERE WAS A HARD, CLEAR SUBSTANCE ON THE PLUNGER. NOTHING HAD BEEN DRAWN INTO THE SYRINGE AT THIS TIME AND BOTH WERE UNUSED AT THIS TIME. R. B. , RN APSM HVC HAS BOTH ITEMS AND THEIR RESPECTIVE PACKAGES AS WELL AS PICTURES OF EACH.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129770 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 3181345 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown