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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 UNKNOWN CHLORAPREP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

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CAREFUSION 213, LLC 0113 UNKNOWN CHLORAPREP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL Back to Search Results
Catalog Number UNKNOWN
Device Problems Fire (1245); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
 
Event Description
Material no.: unknown.Batch no.: unknown.It was reported by the health professional suspected substance or medicinal product missing.Per email: please note that the ema obtained this reference and discarded it based on 4.5 - suspected substance or medicinal product missing.Per final cioms: the surgical procedure was conducted in general anaesthesia (with endo-tracheal tube and 2/l min o2 supply), and chlorhexidine gluconate (2% chlorhexidine gluconate in 70% isopropyl alcohol) (brand name unknown) (chg) was used for skin disinfection of the surgical site.Thyroidectomy was correctly performed, preserving the vagus and recurrent laryngeal nerves integrity by neuromonitoring and identifying and sparing the parathyroid glands.During the closing surgical wound phase, immediately after an intraoperative chg skin disinfection of the neck, a surgical fire (sf) occurred involving surgical drapes of the perioperative field.The fire was most likely produced by the ignition of the reapplied alcohol-based disinfectant by monopolar electrocautery.Although the operating room (or) team promptly extinguished the fire, the patient reported second-third degree burns to the anterolateral surface of the neck.During the hospitalization, the patient clinical conditions remained stable, and the burn lesions were treated with topical and systemic steroid-antibiotic therapy.The subject was discharged on the 5th day of recovery in stable conditions.
 
Manufacturer Narrative
Initially reported "it was reported by the health professional suspected substance or medicinal product missing." further information was provided on the case " he surgical procedure was conducted in general anaesthesia (with endo-tracheal tube and 2/l min o2 supply), and chlorhexidine gluconate (2% chlorhexidine gluconate in 70% isopropyl alcohol) (brand name unknown) (chg) was used for skin disinfection of the surgical site.Thyroidectomy was correctly performed, preserving the vagus and recurrent laryngeal nerves integrity by neuromonitoring and identifying and sparing the parathyroid glands.During the closing surgical wound phase, immediately after an intraoperative chg skin disinfection of the neck, a surgical fire (sf) occurred involving surgical drapes of the perioperative field.The fire was most likely produced by the ignition of the reapplied alcohol-based disinfectant by monopolar electrocautery.Although the operating room (or) team promptly extinguished the fire, the patient reported second-third degree burns to the anterolateral surface of the neck.During the hospitalization, the patient clinical conditions remained stable, and the burn lesions were treated with topical and systemic steroid-antibiotic therapy.The subject was discharged on the 5th day of recovery in stable conditions.Bd was unable to perform a thorough investigation as no sample, were provided.Possible potential causes include: solution is combined with ignition source.Current controls include user instructions and safety instructions that indicate that allowing solution to pool is contraindicated for safety multiple warning labels regarding flammability and use with ignition sources.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.Type of event was updated on supplemental mdr from malfunction to serious injury.
 
Event Description
Material no.: unknown batch no.: unknown.It was reported by the health professional suspected substance or medicinal product missing.Per email: please note that the ema obtained this reference and discarded it based on 4.5 - suspected substance or medicinal product missing.Per final cioms: the surgical procedure was conducted in general anaesthesia (with endo-tracheal tube and 2/l min o2 supply), and chlorhexidine gluconate (2% chlorhexidine gluconate in 70% isopropyl alcohol) (brand name unknown) (chg) was used for skin disinfection of the surgical site.Thyroidectomy was correctly performed, preserving the vagus and recurrent laryngeal nerves integrity by neuromonitoring and identifying and sparing the parathyroid glands.During the closing surgical wound phase, immediately after an intraoperative chg skin disinfection of the neck, a surgical fire (sf) occurred involving surgical drapes of the perioperative field.The fire was most likely produced by the ignition of the reapplied alcohol-based disinfectant by monopolar electrocautery.Although the operating room (or) team promptly extinguished the fire, the patient reported second-third degree burns to the anterolateral surface of the neck.During the hospitalization, the patient clinical conditions remained stable, and the burn lesions were treated with topical and systemic steroid-antibiotic therapy.The subject was discharged on the 5th day of recovery in stable conditions.
 
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Brand Name
UNKNOWN CHLORAPREP
Type of Device
2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
Manufacturer (Section D)
CAREFUSION 213, LLC 0113
1550 northwestern dr
el paso TX 79912
MDR Report Key11877959
MDR Text Key255514448
Report Number3004932373-2021-00259
Device Sequence Number1
Product Code KXF
Combination Product (y/n)Y
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 05/03/2021
Initial Date FDA Received05/25/2021
Supplement Dates Manufacturer Received08/30/2021
Supplement Dates FDA Received08/29/2021
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age65 YR
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