BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUALA DENTAL PRODUCTS

    MDR report key: 2267338 · Received August 31, 2011

    Report

    Report Number
    2522801-2011-00019
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    October 1, 2010
    Report Date
    August 31, 2011
    Manufacturer
    SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
    Product Code
    GAL
    PMA / PMN Number
    K896554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS ESTIMATED. TWO (2) OPENED DEVICES WERE RETURNED FOR EVAL ALONG WITH UNOPENED STERILE PRODUCT FROM THE REPORTED FINISHED GOOD LOTS. THE OPENED DEVICES WERE RE-STERILIZED PRIOR TO BEING EVALUATED. ADD'L ITEM REPORTED BY THIS CUSTOMER: 3-0 CHROMIC GUT: MODEL/CATALOG#: P00636, LOT #: M359920, 510 (K)#: K896554, 3-0 CHROMIC GUT: MODEL. CATALOG #: P00636. LOT# M486730, 510 (K) #: K896554. ANGIOTECH REFERENCE: (B)(4), ITEM # P00635, P00636, QUALA DENTAL PRODUCTS, 4-0 CHROMIC GUT W/C6, 3-0 CHROMIC GUT W/C6 NEEDLE, LOT M292420, M359920, M486730. TWO (2) OPENED DEVICES WERE RETURNED FOR EVAL ALONG WITH UNOPENED STERILE PRODUCT FROM THE REPORTED FINISHED GOOD LOTS. THE OPENED DEVICES WERE RESTERILIZED PRIOR TO BEING REVIEWED UNDER A MICROSCOPE. STERILE SAMPLES FROM EACH OF THE REPORTED FINISHED GOOD LOTS WERE OPENED AND REVIEWED BY THE COMPLAINT SPECIALIST. RESULTS/CONCLUSION - THE RE-STERILIZED DEVICES WERE REMOVED FROM THE STERILIZATION POUCH AND EVALUATED. BOTH SAMPLES WERE RETURNED INSIDE A WRAPPING CARD LABELED 3-0. THE ACTUAL PRINTED FOIL PACKAGES WERE NOT RETURNED TO CONFIRM THE FINISHED GOOD LOT NUMBERS. THE FIRST WRAPPING CARD WAS OPENED AND THERE WERE OBVIOUS SIGNS OF RUST ON THE WRAPPING CARD. THE CARD CONTAINED A LOOSE (DETACHED) NEEDLE ALONG WITH GUT SUTURE THAT STILL REMAINED WRAPPED ON THE CARD. THIS WOULD INDICATE THAT THE DEVICE WAS NOT USED ON A PT. THERE WERE OBVIOUS SIGNS OF RUST ON THE CHANNELED END OF THE NEEDLE. A REMNANT OF SUTURE WAS PROTRUDING FROM THE CHANNELED END OF THE NEEDLE WITH OBVIOUS SIGNS OF RUST PRESENT. IT APPEARS THAT THE SUTURE BROKE AT THE ATTACHMENT DUE TO THE RUST. THE TIP OF THE NEEDLE WAS STILL INTACT AND SHOWED NO SIGNS OF RUST. THE SECOND WRAPPING CARD WAS OPENED AND THERE WERE OBVIOUS SIGNS OF RUST ON THE WRAPPING CARD. THE CARD CONTAINED THE WRAPPED GUT SUTURE WITH A NEEDLE STILL ATTACHED. THIS WOULD INDICATE THAT THE DEVICE WAS NOT USED ON A PT. THERE WERE OBVIOUS SIGNS OF RUST ON THE CHANNELED END OF THE NEEDLE. THE TIP OF THE NEEDLE WAS STILL INTACT AND SHOWED NO SIGNS OF RUST. FIFTY (50) STERILE SAMPLES WERE OPENED AND VISUALLY EXAMINED FOR SIGNS OF RUST. NO RUST WAS PRESENT ON ANY OF THE WRAPPING CARDS OR NEEDLE/SUTURE DEVICES. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS (DHR) FOR THE REPORTED FINISHED GOOD LOTS WERE REVIEWED AND THERE WERE NO CORRESPONDING ISSUES IDENTIFIED DURING MFG OR FINAL RELEASE. TO DATE, NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THE REPORTED FINISHED GOOD LOTS. IT DOES NOT APPEAR AS IF THE RETURNED SAMPLES WERE THE ACTUAL DEVICES THAT BROKE DURING USE. THE RETURNED OPENED SAMPLES DID SHOW SIGNS OF RUST ON THE DEVICES AND ALSO ON THE WRAPPING CARDS. HOWEVER, THIS WOULD HAVE BEEN OBVIOUS UPON OPENING THE WRAPPING CARD, PRIOR TO REMOVING THE PRODUCT. BOTH NEEDLES WERE INTACT WITH NO SIGNS OF RUST ON THE TIPS. THIS COMPLAINT COULD NOT BE CONFIRMED AS REPORTED. A HEALTH HAZARD ASSESSMENT (HHA) WAS PREPARED TO ASSESS POSSIBLE HEALTH RISKS IF A DEVICE WITH RUST PRESENT WERE USED ON A PT. IT WAS DETERMINED THAT NO ADVERSE HEALTH CONSEQUENCES WOULD RESULT FROM THE USE OF THIS DEVICE. SINCE THIS IS NOT AN INDWELLING DEVICE BUT RATHER A DEVICE THAT HAS A BRIEF CONTACT EXPOSURE TIME TO TISSUE, ANY POTENTIAL RESIDUAL OXIDATED IRON OR (B)(4) WOULD AT MOST CAUSE SOME LOCAL IRRITATION OR MINOR TATTOOING. THERE IS NO CONCERN OF TOXICITY SINCE THESE LEVELS (IRON TOXICITY LEVEL IS GREATER THAN 45MG) ARE WELL BELOW ANYTHING ATTAINABLE IN THIS CLINICAL SCENARIO.

    Description of Event or Problem · 1

    THE DATE OF EVENT IS ESTIMATED. THE SECONDARY DISTRIBUTOR RECEIVED THIS COMPLAINT FROM THE DENTIST IN (B)(6) OF 2010. THE SECONDARY DISTRIBUTOR REPORTED THE INCIDENT TO NATIONAL DISTRIBUTION IN (B)(4) 2011. ANGIOTECH DID NOT RECEIVE THE COMPLAINT UNTIL (B)(4), 2011. THE DISTRIBUTOR REPORTED THAT ONE OF THEIR CUSTOMERS RETURNED PRODUCT IN (B)(6) 2011 WITH A NOTE STATING THAT RUST WAS OBSERVED ON NEEDLE TIPS THAT WERE USED FOR DENTAL/ORAL PROCEDURES. IT WAS ALSO NOTED THAT THESE NEEDLES WERE BREAKING WHILE SUTURING DURING THESE PROCEDURES. THE NEEDLES WERE RETRIEVED WITH NO PT INJURY. HOWEVER, THERE IS A POTENTIAL FOR INJURY IF A NEEDLE WERE TO ENTER A PT'S AIRWAY AFTER SUCH A BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUALA DENTAL PRODUCTS SUTURE/NEEDLE GAL SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH) P00635 M292420

    Patients

    Seq Age Sex Outcome Treatment
    1 Other