BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE MINI PEN NEEDLES 5MM (3/16) 31G

    MDR report key: 10210351 · Received June 29, 2020

    Report

    Report Number
    9616656-2020-00610
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 9, 2020
    Report Date
    July 8, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403811012
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 6/29/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (13) 31GX5MM BD PEN NEEDLES FROM LOT 9232978. CONSUMER REPORTED THE FOLLOWING: SHE IS EXPERIENCING PAIN DURING INJECTION, DIFFICULTY ATTACHING SOME OF THE PEN NEEDLES TO HER INSULIN PEN, WHEN SHE REMOVES THE PEN NEEDLES FROM HER INSULIN PEN SHE NOTICES THE NEEDLE IS BENDING, SOMETIMES THE PEN NEEDLES LEAVE A LITTLE BLOOD AT HER INJECTION SITE AND LITTLE SORES ON HER, STATED SOMETIMES DURING HER INJECTIONS THE NEEDLE GETS STUCK IN HER SKIN BUT SHE IS ABLE TO GET IT OUT. ALL 13 RETURNED PEN NEEDLES WERE EXAMINED, AND IT WAS OBSERVED THAT 11 SAMPLES WERE RETURNED AFTER USE, AND 2 SAMPLES WERE RETURNED SEALED/UNUSED. THE 11 USED SAMPLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: - 2 PEN NEEDLES WITH BROKEN PATIENT END (PE) CANNULAS - 5 PEN NEEDLES WITH BENT PE CANNULAS; 2 OF THESE PEN NEEDLES ALSO EXHIBITED BENT NON-PATIENT END (NPE) CANNULAS - 4 PEN NEEDLES WITH STRAIGHT PE AND NPE CANNULAS - ALL 11 PEN NEEDLES WITH STRAIGHT NPE CANNULAS WERE ABLE TO ATTACH/DETACH TO A TEST PEN INJECTOR PROPERLY MICROSCOPIC EXAMINATION OF THE TWO PEN NEEDLES WITH A BROKEN PE CANNULA REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE REMAINING PE CANNULA, AND OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION) ¿ REMOVAL OF THE EPOXY MADE THIS EVIDENT. WHEN VIEWED TOGETHER THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. THE 4 USED PEN NEEDLES WITH STRAIGHT PE AND NPE CANNULAS AND 2 UNUSED PEN NEEDLES WERE THEN TESTED FOR VISUAL INSPECTION OF POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿- 0.0105¿): DATA: POINT (PE/NPE) OUTER DIAMETER (IN) LUBE SAMPLE 1 GOOD/GOOD 0.0103 GOOD SAMPLE 2 GOOD/GOOD 0.0103 GOOD SAMPLE 3 GOOD/GOOD 0.0103 GOOD SAMPLE 4 GOOD/GOOD 0.0103 GOOD SAMPLE 5 GOOD/GOOD 0.0103 GOOD SAMPLE 6 GOOD/GOOD 0.0103 GOOD ALL 6 TESTED PEN NEEDLES TESTED WITHIN SPECIFICATION. SINCE 11 PEN NEEDLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT PE AND NPE CANNULAS IS USER ERROR WHEN USING THE PEN NEEDLES. IF THE USER REMOVES THE CANNULA SHIELD OBLIQUELY, OR IF THEY TRY TO RE-SHIELD/RE-COVER THE PEN NEEDLE, THE PE CANNULA MAY BE BENT DURING THE SHIELD REMOVAL/RE-ATTACHING PROCESS. FURTHERMORE, IF THE USER ATTACHES THE PEN NEEDLE TO THE PEN INJECTOR OBLIQUELY, THE NPE CANNULA MAY BE BENT AND INTERFERE WITH THE THREADS, THUS MAKING IT DIFFICULT TO ATTACH/DETACH THE PEN NEEDLE TO THE PEN INJECTOR. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G EXPERIENCED THE INNER SHIELD OR OUTER COVER/CAP BEING UNABLE TO ATTACH/DETACH AND THE CANNULA BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119 BATCH NO: 9232978 VERBATIM: CONSUMER CALLED BACK FROM VOICEMAIL THAT SHE RECEIVED. STATED SOME PEN NEEDLES COMPLETELY BROKE OFF AND GOT STUCK IN HER SKIN BUT SHE WAS ABLE TO REMOVE THEM. DID NOT SEEK ANY MEDICAL ATTENTION. CONSUMER ALSO REPORTED A NEW PRODUCT COMPLAINT FROM THE SAME LOT #. CONSUMER REPORTED PAIN DURING HER INJECTIONS WITH PEN NEEDLES FROM CURRENT BOX. STATED SHE ALSO HAS DIFFICULTY ATTACHING SOME OF THE PEN NEEDLES TO HER INSULIN PEN. STATED WHEN SHE REMOVES THE PEN NEEDLES FROM HER INSULIN PEN SHE NOTICES THE NEEDLE IS BENDING. STATED SOMETIMES DURING HER INJECTIONS THE NEEDLE GETS STUCK IN HER SKIN BUT SHE IS ABLE TO GET IT OUT. NO MEDICAL ATTENTION NEEDED OR RECEIVED. STATED SOMETIMES THE PEN NEEDLES LEAVE A LITTLE BLOOD AT HER INJECTION SITE AND LITTLE SORES ON HER. STATED SHE IS SPEAKING WITH HER DOCTOR ABOUT SWITCHING TO A DIFFERENT PEN NEEDLE. STATED SHE HAS HAD THESE ISSUES WITH ABOUT HALF OF HER CURRENT BOX. DATE OF EVENT: UNKNOWN

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G EXPERIENCED THE INNER SHIELD OR OUTER COVER/CAP BEING UNABLE TO ATTACH/DETACH AND THE CANNULA BREAKING OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119 BATCH NO: 9232978. VERBATIM: CONSUMER CALLED BACK FROM VOICEMAIL THAT SHE RECEIVED. STATED SOME PEN NEEDLES COMPLETELY BROKE OFF AND GOT STUCK IN HER SKIN BUT SHE WAS ABLE TO REMOVE THEM. DID NOT SEEK ANY MEDICAL ATTENTION. CONSUMER ALSO REPORTED A NEW PRODUCT COMPLAINT FROM THE SAME LOT #. CONSUMER REPORTED PAIN DURING HER INJECTIONS WITH PEN NEEDLES FROM CURRENT BOX. STATED SHE ALSO HAS DIFFICULTY ATTACHING SOME OF THE PEN NEEDLES TO HER INSULIN PEN. STATED WHEN SHE REMOVES THE PEN NEEDLES FROM HER INSULIN PEN SHE NOTICES THE NEEDLE IS BENDING. STATED SOMETIMES DURING HER INJECTIONS THE NEEDLE GETS STUCK IN HER SKIN BUT SHE IS ABLE TO GET IT OUT. NO MEDICAL ATTENTION NEEDED OR RECEIVED. STATED SOMETIMES THE PEN NEEDLES LEAVE A LITTLE BLOOD AT HER INJECTION SITE AND LITTLE SORES ON HER. STATED SHE IS SPEAKING WITH HER DOCTOR ABOUT SWITCHING TO A DIFFERENT PEN NEEDLE. STATED SHE HAS HAD THESE ISSUES WITH ABOUT HALF OF HER CURRENT BOX. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674341 BD ULTRA-FINE MINI PEN NEEDLES 5MM (3/16) 31G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8110 9232978 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other