BEUDAMED
    FDA Adverse Event Other Summary report: N

    1030451-2013-00001

    MDR report key: 3118741 · Received March 28, 2013

    Report

    Report Number
    1030451-2013-00001
    Event Type
    Other
    Date Received
    March 28, 2013
    Product Code
    LRS
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAI HAD RECEIVED AN INITIAL COMPLAINT ON (B)(4) 2012, FROM (B)(6), REGARDING MAI # (B)(4), IV KIT, LOT# 148109 CONTAINING A CHLORAPREP FREPP VIAL. THE COMPLAINT STATED MERELY "GLASS IN THE FOAM, POSSIBLY FROM A BROKEN CHLORAPREP VIAL." WE ASSIGNED MAI COMPLAINT # (B)(4), ENTERED (B)(4) 2012, FOR THIS ISSUE. THERE WAS NO MENTION OF ANY INJURY AS A RESULT OF THIS ISSUE AND EVEN THAT THE GLASS WAS "POSSIBLY" FROM A BROKEN VIAL. WE SENT EMAILS ON (B)(4) 2012 AND (B)(4) 2012 TO (B)(6), COPYING (B)(6) (WHO SUBMITTED THE SUBSEQUENT MDR), ASKING MANY QUESTIONS INCLUDING "WERE THERE ANY REPORTED INJURIES? IF SO, DID THE INJURED PARTY RECEIVE ANY MEDICAL INTERVENTION?" WE ALSO ASKED FOR THEM TO RETURN THE AFFECTED SAMPLE OR A PHOTO OF THE AFFECTED SAMPLE IN ORDER TO INVESTIGATE THE ISSUE MORE COMPLETELY AND EFFECTIVELY. WE NEVER RECEIVED A REPLY TO ANY OF OUR QUESTIONS NOR A SAMPLE OR PHOTO OF THE SAMPLE; THUS WE WERE FORCED TO SEND A CLOSING RESPONSE WITH AN INCONCLUSIVE INVESTIGATION REPORT. WE RECEIVED NO FURTHER REPLY FROM THE CUSTOMER. HOWEVER, ON 02/28/2013, MEDICAL ACTIN INDUSTRIES (MAI), (B)(4) CORPORATE OFFICE RECEIVED MEDWATCH # (B)(4) FROM THE FDA, WHICH WAS FORWARDED TO THE MAI (B)(4) MANUFACTURING FACILITY ON 02/28/2013. THE MDR DESCRIBED THE EVENT OF THE PREVIOUS COMPLAINT BUT AT THIS TIME REPORTED AN INJURY, I.E. "MULTIPLE SUPERFICIAL LACERATIONS" TO THE PT'S ARM WHEN BEING PREPPED FOR A PROCEDURE. IMMEDIATELY UPON RECEIPT OF THE MEDWATCH MAI WAS ABLE TO TALK TO (B)(6) WHO REPORTED THAT THE PT WAS OK: THEY HAD APPLIED ANTIBIOTIC ON THE PT'S ARM. PT REQUIRED NO FURTHER TREATMENT OR CARE. UPON RECEIPT OF THIS MEDWATCH, MAI CONTACTED CAREFUSION. CAREFUSION, THE MFR OF THE CHLORAPREP FREPP AND ISSUED TO THEM SCAR (B)(4) FOR THIS ISSUE. CAREFUSION ASSIGNED COMPLAINT NUMBER (B)(4) TO THIS ISSUE AND RESPONDED TO MAI WITH A LETTER REPORTING THAT FOR BOTH RAW LOTS, THERE WERE NO NON-CONFORMANCES FOUND DURING MANUFACTURE. THEY SUSPECT THAT IF A GLASS SHARD ALIGNED CORRECTLY AGAINST THE FOAM, IT IS SHARP ENOUGH TO PIECE THROUGH THE LINER. GLASS CAN BE PUSHED AGAINST THE FOAM IF THE WINGS OF THE APPLICATOR ARE REPEATEDLY SQUEEZED IN AN ATTEMPT TO PROMOTE THE FLOW OF THE SOLUTION. CAREFUSION ALSO INSTRUCTED THEIR ACCOUNT REP TO CONTACT THE CUSTOMER TO OFFER RE-EDUCATION AND ALSO SENT AN IN-SERVICE POSTER DIRECTLY TO THEM CONTAINING INSTRUCTIONS FOR PROPER USE OF THE CHLORAPREP. CAREFUSION HAS ALSO OPENED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION TO DETERMINE THE ROOT CAUSE(S) FOR THIS ISSUE AND SUGGEST CORRECTIVE AND/OR PREVENTIVE ACTIONS AS MUCH AS CAN BE DETERMINED. THE CAREFUSION SCAR RESPONSE WILL BE REVIEWED AND MAINTAINED ON FILE, AND ANY ADDITIONAL INFO CAREFUSION IS ABLE TO PROVIDE WILL BE COMMUNICATED WITH THE COMPLAINANT. ADDITIONALLY, THIS COMPLAINT HAS BEEN ENTERED INTO OUR POSTMARKET SURVEILLANCE SYSTEM FOR APPROPRIATE TRACKING, TRENDING AND ANY REQUIRED FOLLOW-UP PER OUR STANDARD PROCEDURES.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129589 LRS

    Patients

    Seq Age Sex Outcome Treatment
    1