1/4" (6.4MM) X 10' (3M) 0036290

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 2018-12-17 for 1/4" (6.4MM) X 10' (3M) 0036290 manufactured by Consolidated Medical Equipment.

Event Text Entries

[130628505] The reported device is expected to be returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.
Patient Sequence No: 1, Text Type: N, H10


[130628506] During incoming inspection, the distributor rejected this device, (b)(4) for an insufficient heat seal. 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 Number3007305485-2018-00302
MDR Report Key8171491
Report SourceDISTRIBUTOR,FOREIGN
Date Received2018-12-17
Date of Report2019-01-11
Date Mfgr Received2018-12-19
Device Manufacturer Date2018-02-07
Date Added to Maude2018-12-17
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 ContactMS TRACEY WEISELBENTON
Manufacturer Street11311 CONCEPT BLVD
Manufacturer CityLARGO FL 337734908
Manufacturer CountryUS
Manufacturer Postal337734908
Manufacturer Phone7273995557
Manufacturer G1CONSOLIDATED MEDICAL EQUIPMENT
Manufacturer StreetALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA
Manufacturer CityCHIHUAHUA, MEXICO 31136
Manufacturer CountryMX
Manufacturer Postal Code31136
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1/4" (6.4MM) X 10' (3M)
Generic NameSURGICAL TUBING
Product CodeBYY
Date Received2018-12-17
Returned To Mfg2018-12-19
Catalog Number0036290
Lot Number201802075
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, MEXICO 31136 MX 31136


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-17

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