BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 12506373 · Received September 21, 2021

    Report

    Report Number
    3004932373-2021-00442
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    April 19, 2021
    Report Date
    February 25, 2022
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE WAS PROVIDED. 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. LOT NUMBER PROVIDED WAS FOUND TO BE AN INVALID LOT NUMBER.

    Description of Event or Problem · 0

    MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN (PROVIDED 2101801).   IT WAS REPORTED THAT THE PATIENT¿S CVL (CENTRAL VENOUS LINE) INSERTION SITE HAD GOTTEN RED, IRRITATED AND ITCHY IN THE LAST MONTH (FROM THE DATE OF REPORT). MEDWATCH VERBATIM: CENTRAL VENOUS LINE (CVL) INSERTION SITE HAS GOTTEN RED, IRRITATED AND ITCHY [INJECTION SITE REDNESS]. CENTRAL VENOUS LINE (CVL) INSERTION SITE HAS GOTTEN RED, IRRITATED AND ITCHY [INJECTION SITE IRRITATION]. CENTRAL VENOUS LINE (CVL) INSERTION SITE HAS GOTTEN RED, IRRITATED AND ITCHY [INJECTION SITE ITCHING]. SWEATING A LOT [SWEATING]. WHEN SHE CHANGES HER DRESSING, THE SKIN IS SLOUGHING AND WEEPING [ADHESIVE TAPE ALLERGY]. CASE DESCRIPTION: THIS UNITED STATES CASE IS A SOLICITED REPORT RECEIVED ON (B)(6) 2021 FROM A CONSUMER FROM PATIENT SUPPORT PROGRAM VIA ACCREDO SPECIALTY PHARMACY. THIS 62 YEAR OLD, 158 LB, FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 5 MG/ML), ON (B)(6) 2021 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED AS 0.060 G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. ON AN UNREPORTED DATE IN (B)(6) 2021, THE PATIENT¿S CENTRAL VENOUS LINE INSERTION (CVL) SITE HAS GOTTEN RED, IRRITATED AND ITCHY (INJECTION SITE ERYTHEMA, INJECTION SITE IRRITATION AND INJECTION SITE PRURITUS) AND SWEATING A LOT (HYPERHIDROSIS). ON AN UNREPORTED DATE IN 2021, THE PATIENT EXPERIENCED THE EVENT OF WHEN SHE CHANGES HER DRESSING, THE SKIN IS SLOUGHING AND WEEPING (DERMATITIS CONTACT). CO SUSPECT MEDICATION INCLUDED CHLORAPREP (CHLORHEXIDINE GLUCONATE, ISOPROPANOL). CONCOMITANT MEDICATIONS INCLUDED OPSUMIT (MACITENTAN) AND TADALAFIL. RELEVANT MEDICAL HISTORY INCLUDED PRIMARY PULMONARY ARTERIAL HYPERTENSION. IT WAS REPORTED THAT THE PATIENT¿S CVL (CENTRAL VENOUS LINE) INSERTION SITE HAD GOTTEN RED, IRRITATED AND ITCHY IN THE LAST MONTH (FROM THE DATE OF REPORT). SHE HAD BEEN WORKING OUTSIDE IN HER YARD AND THUS WAS SWEATING A LOT IN THE LAST MONTH (FROM THE DATE OF REPORT). FURTHERMORE, WHEN SHE CHANGED THE DRESSING, THE SKIN WAS SLOUGHING OFF AND WEEPING. SHE USED CHLORAPREP AND IV3000 FOR THE CVL DRESSING CHANGES AND HER NURSE WAS COMING TO ASSESS HER SITE TODAY (ON (B)(6) 2021). HER PHYSICIAN SAW IT THIS WEEK AND HAD NO RECOMMENDATIONS. ACTION TAKEN WITH IV REMODULIN WAS NOT REPORTED FOR THE EVENTS OF INJECTION SITE ERYTHEMA, INJECTION SITE IRRITATION, INJECTION SITE PRURITUS, HYPERHIDROSIS AND DERMATITIS CONTACT. AT THE TIME OF REPORTING, THE OUTCOME OF INJECTION SITE ERYTHEMA, INJECTION SITE IRRITATION, INJECTION SITE PRURITUS, HYPERHIDROSIS AND DERMATITIS CONTACT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENTS OF INJECTION SITE ERYTHEMA, INJECTION SITE IRRITATION, INJECTION SITE PRURITUS, HYPERHIDROSIS AND DERMATITIS CONTACT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN (PROVIDED 2101801).   IT WAS REPORTED THAT THE PATIENT¿S CVL (CENTRAL VENOUS LINE) INSERTION SITE HAD GOTTEN RED, IRRITATED AND ITCHY IN THE LAST MONTH (FROM THE DATE OF REPORT). MEDWATCH VERBATIM: CENTRAL VENOUS LINE (CVL) INSERTION SITE HAS GOTTEN RED, IRRITATED AND ITCHY [INJECTION SITE REDNESS]. CENTRAL VENOUS LINE (CVL) INSERTION SITE HAS GOTTEN RED, IRRITATED AND ITCHY [INJECTION SITE IRRITATION]. CENTRAL VENOUS LINE (CVL) INSERTION SITE HAS GOTTEN RED, IRRITATED AND ITCHY [INJECTION SITE ITCHING]. SWEATING A LOT [SWEATING]. WHEN SHE CHANGES HER DRESSING, THE SKIN IS SLOUGHING AND WEEPING [ADHESIVE TAPE ALLERGY]. CASE DESCRIPTION: THIS UNITED STATES CASE IS A SOLICITED REPORT RECEIVED ON (B)(6) 2021 FROM A CONSUMER FROM PATIENT SUPPORT PROGRAM VIA (B)(6) PHARMACY. THIS (B)(6) YEAR OLD, (B)(6) , FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 5 MG/ML), ON (B)(6) 2021 FOR PRIMARY PULMONARY ARTERIAL HYPERTENSION. THE CURRENT DOSE WAS REPORTED AS 0.060 G/KG, CONTINUOUS VIA INTRAVENOUS (IV) ROUTE. ON AN UNREPORTED DATE IN (B)(6) 2021, THE PATIENT¿S CENTRAL VENOUS LINE INSERTION (CVL) SITE HAS GOTTEN RED, IRRITATED AND ITCHY (INJECTION SITE ERYTHEMA, INJECTION SITE IRRITATION AND INJECTION SITE PRURITUS) AND SWEATING A LOT (HYPERHIDROSIS). ON AN UNREPORTED DATE IN 2021, THE PATIENT EXPERIENCED THE EVENT OF WHEN SHE CHANGES HER DRESSING, THE SKIN IS SLOUGHING AND WEEPING (DERMATITIS CONTACT). CO SUSPECT MEDICATION INCLUDED CHLORAPREP (CHLORHEXIDINE GLUCONATE, ISOPROPANOL). CONCOMITANT MEDICATIONS INCLUDED OPSUMIT (MACITENTAN) AND TADALAFIL. RELEVANT MEDICAL HISTORY INCLUDED PRIMARY PULMONARY ARTERIAL HYPERTENSION. IT WAS REPORTED THAT THE PATIENT¿S CVL (CENTRAL VENOUS LINE) INSERTION SITE HAD GOTTEN RED, IRRITATED AND ITCHY IN THE LAST MONTH (FROM THE DATE OF REPORT). SHE HAD BEEN WORKING OUTSIDE IN HER YARD AND THUS WAS SWEATING A LOT IN THE LAST MONTH (FROM THE DATE OF REPORT). FURTHERMORE, WHEN SHE CHANGED THE DRESSING, THE SKIN WAS SLOUGHING OFF AND WEEPING. SHE USED CHLORAPREP AND IV3000 FOR THE CVL DRESSING CHANGES AND HER NURSE WAS COMING TO ASSESS HER SITE TODAY (ON (B)(6) 2021). HER PHYSICIAN SAW IT THIS WEEK AND HAD NO RECOMMENDATIONS. ACTION TAKEN WITH IV REMODULIN WAS NOT REPORTED FOR THE EVENTS OF INJECTION SITE ERYTHEMA, INJECTION SITE IRRITATION, INJECTION SITE PRURITUS, HYPERHIDROSIS AND DERMATITIS CONTACT. AT THE TIME OF REPORTING, THE OUTCOME OF INJECTION SITE ERYTHEMA, INJECTION SITE IRRITATION, INJECTION SITE PRURITUS, HYPERHIDROSIS AND DERMATITIS CONTACT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENTS OF INJECTION SITE ERYTHEMA, INJECTION SITE IRRITATION, INJECTION SITE PRURITUS, HYPERHIDROSIS AND DERMATITIS CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403467 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Other