PORTEX GENERAL ANESTHESIA CIRCUIT C45101340-NLJ

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-03-07 for PORTEX GENERAL ANESTHESIA CIRCUIT C45101340-NLJ manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[138159211] Lot number: lot contains the following possible numbers: 180528. (b)(6). Device evaluation: one breathing circuit was received for investigation. The sample was received in used condition without its original packaging. Immediate visual inspection detected a hole in the product. A leak functional test was completed and the device did not pass. In addition, leak tests were audited in order to verify that all components were free of damage or defects. Thirty two (32) units were reviewed and no discrepancies were found. A review of the manufacturing process was also conducted and was considered adequate and correct. Based on the evidence and testing, the complaint allegation was confirmed. The root cause was listed as unknown.
Patient Sequence No: 1, Text Type: N, H10


[138159212] Information was received that a smiths medical portex general anesthesia circuit had a small pinhole leak while in use. The issue was discovered after hearing an air leak sound and it was reported they were able to cover the pinhole with tape. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2019-01275
MDR Report Key8401517
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-03-07
Date of Report2019-03-07
Date of Event2018-10-19
Date Mfgr Received2019-02-05
Date Added to Maude2019-03-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer G1SMITHS MEDICAL INTERNATIONAL LTD.
Manufacturer StreetBOUNDARY ROAD, HYTHE KENT CT21 6JL
Manufacturer CityKENT,
Manufacturer CountryUK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX GENERAL ANESTHESIA CIRCUIT
Generic NameCIRCULATOR, BREATHING-CIRCUIT
Product CodeCAG
Date Received2019-03-07
Returned To Mfg2019-02-26
Catalog NumberC45101340-NLJ
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.