BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SLIP TIP SYRINGE W/ ATTACHED NEEDLE

    MDR report key: 8691755 · Received June 12, 2019

    Report

    Report Number
    1213809-2019-00612
    Event Type
    Injury
    Date Received
    June 12, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K980580
    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: PMA/510(K)#: K980580.

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING A HARD TIME REMOVING THE CAP FROM BD¿ SLIP TIP SYRINGE W/ ATTACHED NEEDLE AND HAD A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309597, BATCH NO. 9070752. IT WAS REPORTED THE CUSTOMER HAD TROUBLE REMOVING THE SYRINGE CAP AND HAD A NEEDLE STICK. AN INVESTIGATION IS REQUIRED. VERBATIM: A REPORT WAS RECEIVED 17MAY2019 VIA MED INFO. RECEIVED A CALL ON 17 MAY2019 WARM TRANSFERRED FROM SHIRE AE LINE, WITH ONBOARDING ACCESS SPECIALIST REPORTING AN AE/PQC FOR GATTEX. THE CALLER STATES: I HAD A CALL TODAY FROM A PATIENT WHO IS HAVING PROBLEMS GETTING THE CAP OFF OF THE DILUENT (FOR GATTEX) TODAY SHE SAID SOME OF THE DILUENT CAPS ARE MORE DIFFICULT THAN OTHERS TO GET OFF. SHE REPORTED SHE HAD A NEEDLE STICK AS WELL TODAY. THE PATIENT STATED HER DOSE TODAY WAS DELAYED DUE TO THIS PROBLEM AND SHE WILL TRY AGAIN LATER ON WITH OTHER BOTTLES OF THE DILUENT SHE HAS IN HER SUPPLY. THE PATIENT WOULD LIKE MORE TRAINING WITH THIS FROM A NURSE AND I WILL BE CONTACTING ONE PATH TO ASSIST WITH HER. THE CALLER STATES IT IS UNKNOWN IF PRODUCT HAS BEEN RETAINED BY PATIENT FOR POTENTIAL RETURN. (B)(6) 2019- CALLED PATIENT. SHE REPORTED SHE ACTUALLY HAD TROUBLE REMOVING THE SYRINGE CAP FROM THE SYRINGE SHE USES TO INJECT THE MEDICINE. SHE KEEPS THE NEEDLE STRAIGHT AND PULLS CAP OFF STRAIGHT. NOW USES HER THUMB TO REMOVE CAP SO SHE DOESN'T JAB HERSELF ANYMORE. SHE REPORTED THIS TO MEDINFO ALREADY. PROVIDED A KIT LOT NUMBER AV19094AA AND SAID IT HAPPENED WITH A PREVIOUS KIT AS WELL. THIS RECORD WILL BE UPDATED ACCORDINGLY AND A RECORD FOR A NO LOT WILL BE ADDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING A HARD TIME REMOVING THE CAP FROM BD¿ SLIP TIP SYRINGE W/ ATTACHED NEEDLE AND HAD A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309597 BATCH NO. 9070752. IT WAS REPORTED THE CUSTOMER HAD TROUBLE REMOVING THE SYRINGE CAP AND HAD A NEEDLE STICK. AN INVESTIGATION IS REQUIRED. VERBATIM: A REPORT WAS RECEIVED 17MAY2019 VIA MED INFO. RECEIVED A CALL ON (B)(6) 2019 WARM TRANSFERRED FROM SHIRE AE LINE, WITH ONBOARDING ACCESS SPECIALIST REPORTING AN AE/PQC FOR GATTEX. THE CALLER STATES: I HAD A CALL TODAY FROM A PATIENT WHO IS HAVING PROBLEMS GETTING THE CAP OFF OF THE DILUENT (FOR GATTEX) TODAY SHE SAID SOME OF THE DILUENT CAPS ARE MORE DIFFICULT THAN OTHERS TO GET OFF. SHE REPORTED SHE HAD A NEEDLE STICK AS WELL TODAY. THE PATIENT STATED HER DOSE TODAY WAS DELAYED DUE TO THIS PROBLEM AND SHE WILL TRY AGAIN LATER ON WITH OTHER BOTTLES OF THE DILUENT SHE HAS IN HER SUPPLY. THE PATIENT WOULD LIKE MORE TRAINING WITH THIS FROM A NURSE AND I WILL BE CONTACTING ONE PATH TO ASSIST WITH HER. THE CALLER STATES IT IS UNKNOWN IF PRODUCT HAS BEEN RETAINED BY PATIENT FOR POTENTIAL RETURN. ON (B)(6) 2019- CALLED PATIENT. SHE REPORTED SHE ACTUALLY HAD TROUBLE REMOVING THE SYRINGE CAP FROM THE SYRINGE SHE USES TO INJECT THE MEDICINE. SHE KEEPS THE NEEDLE STRAIGHT AND PULLS CAP OFF STRAIGHT. NOW USES HER THUMB TO REMOVE CAP SO SHE DOESN'T JAB HERSELF ANYMORE. SHE REPORTED THIS TO MEDINFO ALREADY. PROVIDED A KIT LOT NUMBER AV19094AA AND SAID IT HAPPENED WITH A PREVIOUS KIT AS WELL. THIS RECORD WILL BE UPDATED ACCORDINGLY AND A RECORD FOR A NO LOT WILL BE ADDED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING A HARD TIME REMOVING THE CAP FROM BD¿ SLIP TIP SYRINGE W/ ATTACHED NEEDLE AND HAD A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309597, BATCH NO. 9070752. IT WAS REPORTED THE CUSTOMER HAD TROUBLE REMOVING THE SYRINGE CAP AND HAD A NEEDLE STICK. AN INVESTIGATION IS REQUIRED. VERBATIM: A REPORT WAS RECEIVED (B)(6) 2019 VIA MED INFO. RECEIVED A CALL ON (B)(6) 2019, (B)(6), WITH ONBOARDING ACCESS SPECIALIST REPORTING AN AE/PQC FOR GATTEX. THE CALLER STATES: I HAD A CALL TODAY FROM A PATIENT WHO IS HAVING PROBLEMS GETTING THE CAP OFF OF THE DILUENT (FOR GATTEX) TODAY SHE SAID SOME OF THE DILUENT CAPS ARE MORE DIFFICULT THAN OTHERS TO GET OFF. SHE REPORTED SHE HAD A NEEDLE STICK AS WELL TODAY. THE PATIENT STATED HER DOSE TODAY WAS DELAYED DUE TO THIS PROBLEM AND SHE WILL TRY AGAIN LATER ON WITH OTHER BOTTLES OF THE DILUENT SHE HAS IN HER SUPPLY. THE PATIENT WOULD LIKE MORE TRAINING WITH THIS FROM A NURSE AND I WILL BE CONTACTING ONE PATH TO ASSIST WITH HER. THE CALLER STATES IT IS UNKNOWN IF PRODUCT HAS BEEN RETAINED BY PATIENT FOR POTENTIAL RETURN. ON (B)(6) 2019- CALLED PATIENT. SHE REPORTED SHE ACTUALLY HAD TROUBLE REMOVING THE SYRINGE CAP FROM THE SYRINGE SHE USES TO INJECT THE MEDICINE. SHE KEEPS THE NEEDLE STRAIGHT AND PULLS CAP OFF STRAIGHT. NOW USES HER THUMB TO REMOVE CAP, SO SHE DOESN'T JAB HERSELF ANYMORE. SHE REPORTED THIS TO MEDINFO ALREADY. PROVIDED A KIT LOT NUMBER AV19094AA AND SAID IT HAPPENED WITH A PREVIOUS KIT AS WELL. THIS RECORD WILL BE UPDATED ACCORDINGLY AND A RECORD FOR A NO LOT WILL BE ADDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484829 BD SLIP TIP SYRINGE W/ ATTACHED NEEDLE SYRINGE W/ NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 9070752 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Other