MAUDE Adverse Event Report: CAREFUSION, INC UNKNOWN CHLORAPREP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 02/09/2021

Event Type  Injury  

Manufacturer Narrative

(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.

Event Description

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].

• Brand Name: UNKNOWN CHLORAPREP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11358514
• MDR Text Key: 242423798
• Report Number: 1423507-2021-00007
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other