BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB

    MDR report key: 8660565 · Received May 31, 2019

    Report

    Report Number
    1920898-2019-00503
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 12, 2019
    Report Date
    June 25, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903055006
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    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 HAVE BEEN UPDATED WITH CORRECTIONS: G.5. PMA/510(K)#: K980580, K941657.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) 1CC, 12.7MM, 28G BD ALLERGY SYRINGES IN AN OPEN POLY BAG WITH A WORN OUT, ILLEGIBLE LOT NUMBER. CUSTOMER STATES THAT SHE WAS STUCK WITH THE NEEDLE THAT WAS BENT THROUGH THE SHIELD. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SYRINGE EXHIBITED A BENT CANNULA AND A HOLE IN THE SHIELD. THIS INDICATES THAT THE CANNULA WAS THROUGH THE SHIELD, EXPOSING THE CANNULA, WHICH COULD LEAD TO A NEEDLE STICK. A DHR CHECK WAS NOT PERFORMED AS THE LOT NUMBER IS "UNKNOWN" FOR THIS COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AS PER MANUFACTURING, "PROBABLE ROOT CAUSE FOR THE DAMAGE TO THE BARREL IS FROM THE EXPOSED CANNULA ON THE SYRINGE GETTING CAUGHT IN THE WEB MATERIAL DURING THE FORM, FILL, AND SEAL PROCESS. THE BARREL OF THE SYRINGE WOULD HAVE BEEN CAUGHT IN THE JAWS THAT SEAL THE POLYBAG. PROBABLE ROOT CAUSE FOR THE CANNULA PIERCED THROUGH THE SHIELD IS A MISALIGNMENT DURING THE SHIELDING PROCESS AT THE PILS. CAPA 529089 FOR NEEDLE THROUGH SHIELD ON ALLERGY SYRINGES WAS IMPLEMENTED ON (B)(6) 2019 WHICH IS AFTER THE DATE OF MANUFACTURE THAT IS MARKED ON THE POLYBAG. " COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB PENETRATED THROUGH SHIELD AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305500 BATCH NO: UNKNOWN IT WAS REPORTED THAT THE SYRINGE NEEDLE STUCK HER FINGER AS SHE WAS PREPARING FOR HER INJECTION SHE IS CONCERNED THAT THE NEEDLE MAY CAUSE AN INFECTION. VERBATIM: CONSUMER REPORTED THAT THE SYRINGE NEEDLE STUCK HER FINGER AS SHE WAS PREPARING FOR HER INJECTION. SHE STATED THAT SHE TOOK THE SYRINGE OUT OF THE BAG AND PUT IT ON THE COUNTER AND WHEN SHE PICKED IT UP SHE WAS STUCK WITH THE NEEDLE THAT WAS BENT THROUGH THE SHIELD. CONSUMER DID NOT SEEK MEDICAL ATTENTION BUT SHE IS CONCERNED THAT THE NEEDLE MAY CAUSE AN INFECTION. SHE WILL CONTACT US WITH ANY UPDATES IF SHE GOES TO THE DOCTOR. PROBLEM OCCURRED ON (B)(6) 2019, LOT # IS UNAVAILABLE, PRODUCT # 305500, NO EXP DATE. CONSUMER WILL SEND SAMPLE AND POLY BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB PENETRATED THROUGH SHIELD AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305500 BATCH NO: UNKNOWN IT WAS REPORTED THAT THE SYRINGE NEEDLE STUCK HER FINGER AS SHE WAS PREPARING FOR HER INJECTION SHE IS CONCERNED THAT THE NEEDLE MAY CAUSE AN INFECTION. VERBATIM: CONSUMER REPORTED THAT THE SYRINGE NEEDLE STUCK HER FINGER AS SHE WAS PREPARING FOR HER INJECTION. SHE STATED THAT SHE TOOK THE SYRINGE OUT OF THE BAG AND PUT IT ON THE COUNTER AND WHEN SHE PICKED IT UP SHE WAS STUCK WITH THE NEEDLE THAT WAS BENT THROUGH THE SHIELD. CONSUMER DID NOT SEEK MEDICAL ATTENTION BUT SHE IS CONCERNED THAT THE NEEDLE MAY CAUSE AN INFECTION. SHE WILL CONTACT US WITH ANY UPDATES IF SHE GOES TO THE DOCTOR. PROBLEM OCCURRED ON (B)(6) 2019, LOT # IS UNAVAILABLE, PRODUCT # 305500, NO EXP DATE. CONSUMER WILL SEND SAMPLE AND POLY BAG.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ SYRINGE ALLERGY 1 ML W/ NEEDLE 28X1/2 RB PENETRATED THROUGH SHIELD AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305500. BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE SYRINGE NEEDLE STUCK HER FINGER AS SHE WAS PREPARING FOR HER INJECTION SHE IS CONCERNED THAT THE NEEDLE MAY CAUSE AN INFECTION. VERBATIM: CONSUMER REPORTED THAT THE SYRINGE NEEDLE STUCK HER FINGER AS SHE WAS PREPARING FOR HER INJECTION. SHE STATED THAT SHE TOOK THE SYRINGE OUT OF THE BAG AND PUT IT ON THE COUNTER AND WHEN SHE PICKED IT UP SHE WAS STUCK WITH THE NEEDLE THAT WAS BENT THROUGH THE SHIELD. CONSUMER DID NOT SEEK MEDICAL ATTENTION BUT SHE IS CONCERNED THAT THE NEEDLE MAY CAUSE AN INFECTION. SHE WILL CONTACT US WITH ANY UPDATES IF SHE GOES TO THE DOCTOR. PROBLEM OCCURRED ON (B)(6) 2019, LOT # IS UNAVAILABLE, PRODUCT # 305500, NO EXP DATE. CONSUMER WILL SEND SAMPLE AND POLY BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454502 BD PRECISIONGLIDE SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB ALLERGY SYRINGE & NEEDLE FMF BD MEDICAL - DIABETES CARE UNKNOWN 30382903055006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other