BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 11358514 · Received February 22, 2021

    Report

    Report Number
    1423507-2021-00007
    Event Type
    Injury
    Date Received
    February 22, 2021
    Date of Event
    February 9, 2021
    Report Date
    February 11, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). PER LITERATURE: OBJECTIVE: EMERGENT CESAREAN DELIVERY (CD) CARRIES A HIGH RISK FOR POSTPARTUM INFECTION. IN CASES WITH A "SPLASH" POVIDONE-IODINE (PI) SKIN PREPARATION, PROPHYLACTIC POSTOPERATIVE ANTIBIOTICS (PP-ABX) ARE SOMETIMES UTILIZED, BUT THE BENEFIT IS UNCLEAR. WE SOUGHT TO DETERMINE IF USE OF PP-ABX DECREASES POSTPARTUM INFECTION AFTER EMERGENT CD WITH PI SKIN PREPARATION. STUDY DESIGN: COHORT STUDY OF WOMEN UNDERGOING EMERGENT CD WITH PI SKIN PREPARATION FROM JULY 2012 TO APRIL 2020 AT A SINGLE INSTITUTION. CASES WERE IDENTIFIED USING A NATURAL LANGUAGE SEARCH ENGINE, DEEP-6, WITH KEY TERMS "EMERGENT" AND "CESAREAN DELIVERY". WOMEN WITH CHORIOAMNIONITIS OR NON-PI SKIN PREPARATION (E.G., CHLORHEXIDINE) WERE EXCLUDED. THE PRIMARY EXPOSURE WAS USE OF PP-ABX. THE PRIMARY OUTCOME WAS POSTPARTUM INFECTION, DEFINED AS A COMPOSITE: ENDOMETRITIS, WOUND INFECTION, CELLULITIS, SEROMA, HEMATOMA, OR INTRA-ABDOMINAL ABSCESS. RATES OF POSTPARTUM INFECTION WERE STRATIFIED BY USE OF PP-ABX. DEMOGRAPHIC AND LABOR CHARACTERISTICS WERE EVALUATED AS CONFOUNDERS. STATISTICS BY ¿2, T-TEST AND LOGISTIC REGRESSION (¿=0.05). RESULTS: IN TOTAL, 489 WOMEN UNDERWENT EMERGENT CD; OF THOSE, 370 HAD PI SKIN PREPARATION AND WERE INCLUDED. PP-ABX WERE GIVEN IN 43% (160/370) OF CASES, INCLUDING: CEFAZOLIN (N=137), GENTAMICIN/CLINDAMYCIN (N=18), AZITHROMYCIN (N=3), AND VANCOMYCIN (N=2). THOSE RECEIVING PP-ABX WERE SIMILAR TO THOSE WHO DID NOT, EXCEPT THE PP-ABX GROUP WAS YOUNGER WITH LONGER CD DURATION (TABLE 1). THE RATE OF POSTPARTUM INFECTION WAS NO DIFFERENT IN WOMEN WHO RECEIVED PP-ABX COMPARED TO THOSE WHO DID NOT (12.6% VS 9.5%, P=0.34) (TABLE 2). THIS FINDING REMAINED UNCHANGED AFTER MULTIVARIABLE ADJUSTMENT (AOR 1.2, CI 0.61-2.4, P=0.60). MOREOVER, THE RATE OF POSTPARTUM INFECTION DID NOT VARY BY ANTIBIOTIC CHOICE. CONCLUSION: AFTER EMERGENT CD WITH PI SKIN PREPARATION, ROUTINE USE OF PROPHYLACTIC POSTOPERATIVE ANTIBIOTICS DOES NOT APPEAR TO REDUCE THE RATE OF POSTPARTUM INFECTION, WHICH IS IMPORTANT AS WE CONSIDER ANTIBIOTIC STEWARDSHIP. MORE STUDIES ARE NEEDED TO IDENTIFY TREATMENTS THAT DECREASE INFECTIOUS MORBIDITY WITH EMERGENT CD. [FORMULA PRESENTED] [FORMULA PRESENTED] NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER OR AUTHOR OF THE ARTICLE - FOR LIT REVIEW). PRIMEVIGILANCE DID REACH OUT TO OBTAIN WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A STUDY THERE WAS DRUG EXPOSURE DURING PREGNANCY AND POSTPARTUM INFECTION. PER LITERATURE: OBJECTIVE: EMERGENT CESAREAN DELIVERY (CD) CARRIES A HIGH RISK FOR POSTPARTUM INFECTION. IN CASES WITH A "SPLASH" POVIDONE-IODINE (PI) SKIN PREPARATION, PROPHYLACTIC POSTOPERATIVE ANTIBIOTICS (PP-ABX) ARE SOMETIMES UTILIZED, BUT THE BENEFIT IS UNCLEAR. WE SOUGHT TO DETERMINE IF USE OF PP-ABX DECREASES POSTPARTUM INFECTION AFTER EMERGENT CD WITH PI SKIN PREPARATION. STUDY DESIGN: COHORT STUDY OF WOMEN UNDERGOING EMERGENT CD WITH PI SKIN PREPARATION FROM JULY 2012 TO APRIL 2020 AT A SINGLE INSTITUTION. CASES WERE IDENTIFIED USING A NATURAL LANGUAGE SEARCH ENGINE, DEEP-6, WITH KEY TERMS "EMERGENT" AND "CESAREAN DELIVERY". WOMEN WITH CHORIOAMNIONITIS OR NON-PI SKIN PREPARATION (E.G., CHLORHEXIDINE) WERE EXCLUDED. THE PRIMARY EXPOSURE WAS USE OF PP-ABX. THE PRIMARY OUTCOME WAS POSTPARTUM INFECTION, DEFINED AS A COMPOSITE: ENDOMETRITIS, WOUND INFECTION, CELLULITIS, SEROMA, HEMATOMA, OR INTRA-ABDOMINAL ABSCESS. RATES OF POSTPARTUM INFECTION WERE STRATIFIED BY USE OF PP-ABX. DEMOGRAPHIC AND LABOR CHARACTERISTICS WERE EVALUATED AS CONFOUNDERS. STATISTICS BY ¿2, T-TEST AND LOGISTIC REGRESSION (¿=0.05). RESULTS: IN TOTAL, 489 WOMEN UNDERWENT EMERGENT CD; OF THOSE, 370 HAD PI SKIN PREPARATION AND WERE INCLUDED. PP-ABX WERE GIVEN IN 43% (160/370) OF CASES, INCLUDING: CEFAZOLIN (N=137), GENTAMICIN/CLINDAMYCIN (N=18), AZITHROMYCIN (N=3), AND VANCOMYCIN (N=2). THOSE RECEIVING PP-ABX WERE SIMILAR TO THOSE WHO DID NOT, EXCEPT THE PP-ABX GROUP WAS YOUNGER WITH LONGER CD DURATION (TABLE 1). THE RATE OF POSTPARTUM INFECTION WAS NO DIFFERENT IN WOMEN WHO RECEIVED PP-ABX COMPARED TO THOSE WHO DID NOT (12.6% VS 9.5%, P=0.34) (TABLE 2). THIS FINDING REMAINED UNCHANGED AFTER MULTIVARIABLE ADJUSTMENT (AOR 1.2, CI 0.61-2.4, P=0.60). MOREOVER, THE RATE OF POSTPARTUM INFECTION DID NOT VARY BY ANTIBIOTIC CHOICE. CONCLUSION: AFTER EMERGENT CD WITH PI SKIN PREPARATION, ROUTINE USE OF PROPHYLACTIC POSTOPERATIVE ANTIBIOTICS DOES NOT APPEAR TO REDUCE THE RATE OF POSTPARTUM INFECTION, WHICH IS IMPORTANT AS WE CONSIDER ANTIBIOTIC STEWARDSHIP. MORE STUDIES ARE NEEDED TO IDENTIFY TREATMENTS THAT DECREASE INFECTIOUS MORBIDITY WITH EMERGENT CD. [FORMULA PRESENTED] [FORMULA PRESENTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256517 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXF CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other