1/4" (6.4MM) X 12' (3.7M) 0036550

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-02-06 for 1/4" (6.4MM) X 12' (3.7M) 0036550 manufactured by Consolidated Medical Equipment.

Event Text Entries

[135210653] The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10


[135210654] During incoming inspection, the distributor rejected this device, 0036550, for an insufficient heatseal. There was no contact with the patient as this was found during incoming inspection. Due to the potential severity of a breach in sterility, this complaint meets the criteria for a reportable event. This will be reported as a malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007305485-2019-00040
MDR Report Key8311970
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-02-06
Date of Report2019-03-07
Date Mfgr Received2019-03-05
Device Manufacturer Date2018-01-18
Date Added to Maude2019-02-06
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 ContactMR. JOHN BERGA
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995358
Manufacturer G1CONSOLIDATED MEDICAL EQUIPMENT
Manufacturer StreetALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA
Manufacturer CityCHIHUAHUA, 31136
Manufacturer CountryMX
Manufacturer Postal Code31136
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1/4" (6.4MM) X 12' (3.7M)
Generic NameTUBE, ASPIRATING, FLEXIBLE, CONNECTING
Product CodeBYY
Date Received2019-02-06
Returned To Mfg2019-01-31
Catalog Number0036550
Lot Number201801185
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCONSOLIDATED MEDICAL EQUIPMENT
Manufacturer AddressALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, 31136 MX 31136


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-06

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