3M'S CUROS DISINFECTING CAPS 001-270 CFFI-270

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for 3M'S CUROS DISINFECTING CAPS 001-270 CFFI-270 manufactured by 3m Health Care.

Event Text Entries

[78997210] Concerns regarding the use of 3m's curos disinfecting caps for needless connectors in neonates. Curos caps are imbedded with 70% isopropyl alcohol. It is used to reduce the incidence of infections. Background: in 1982 two groups of investigators. Gershanik in new orleans and brown in portland concluded that "intravenous solutions of flush solutions containing 0. 9% benzyl alcohol caused severe metabolic acidosis, encephalopathy, respiratory depression and gasping, and perhaps other abnormalities leading to death of a total of 16 infants. Blood and urine from several affected infants had high levels of both benzoic and hippuric acids, known metabolites of benzyl alcohol. Both group stated that no add'l cases occurred after solutions with benzyl alcohol preservative were banned from their nurseries. " (american academy of pediatrics, benzyl alcohol toxic agent in neonatal units. In 1983 the fda, the cdc and the american academy of pediatrics recommended the elimination of benzyl alcohol as a preservative in iv solution and diluents used to reconstitute or dilute medications for infants. In 2000 stremski reported that 70% isopropyl alcohol plasma concentration of >25 mg/dl is toxic for infants; in 2015 sauron and colleagues examined the safety of the swabcap, another disinfection cap (excelsior medical) also imbedded with 70% isopropyl alcohol. It is small bench study. The authors used the swabcap to cap smartsite and caresite connectors and found "the visual appearance of all smartsite valves and 67% of the caresite valves was changed by swabcap use. The mean isopropyl alcohol dosages were 52 mmol/l in the smartsite and 8mmol/l in the caresite at room temperature and 72 and 7 mmol/l, respectively, at 35 degrees c. No alcohol was found in the control circuit. " the control circuit followed standard care, which consisted of disinfecting the luer access valve before injections using friction with an isopropyl alcohol pad for 15 seconds followed by a drying time of 15 seconds. The authors recommended that the swabcap "should not be used for neonates without further research"; references: american academy of pediatrics, benzyl alcohol: toxic agent in neonatal units. Pediatrics, 1983, 72(3): p. 356-8. Stremski, e. And h. Hennes, accidental isopropanol ingestion in children. Pedtr emerg care, 2000. 16(4): p. 238-40. Sauron, c. , p. Jouvet, g. Pinard, d. Goudreault, b. Martin, b. Rival and a. Moussa, using isopropyl alcohol impregnated disinfection caps in the neonatal intensive care unit can cause isopropyl alcohol toxicity. Acta pediatr, 2015. 104(11): p. E489-93. Vivier, p. M. , w. J. Lewander, h. F. Martin and j. G. Linakis, isopropyl alcohol intoxication in a neonate through chronic dermal exposure a complication of a culturally-based umbilical care practice. Pediatr emerg care, 1994; 10(2): p. 91-3. Sivilotti, m. L. A. , isopro;yl alcohol poisoning. Up to date, 2015. Version 12 (topic 334). Mydler t. T. , g. S. Wasserman, w. A. Watson and j. F. Knapp, two-week-old infant with isopropanol intoxication. Pediatr emerg care, 1993. 9(3): p. 146-8.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5070690
MDR Report Key6676510
Date Received2017-06-27
Date of Report2017-06-27
Date of Event2017-05-24
Date Added to Maude2017-06-29
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name3M'S CUROS DISINFECTING CAPS
Generic NameCUROS CAPS
Product CodeLKB
Date Received2017-06-27
Model Number001-270
Catalog NumberCFFI-270
Lot Number20150619-03
Device Expiration Date2018-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer AddressST. PAUL MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-06-27

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