SUCT CTH KIT W/O SOL SFTY-VAC 10FR 37024

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for SUCT CTH KIT W/O SOL SFTY-VAC 10FR 37024 manufactured by Kenmex.

Event Text Entries

[40418010] (b)(4). An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[40418011] It was reported to covidien on (b)(6) 2013 that a customer had an issue with a gauze sponge. The customer reports: suction catheters used for suctioning mucus when a trach is already in place. The suction catheters are occluded and not suctioning correctly. No air flow is going through to produce suctioning.
Patient Sequence No: 1, Text Type: D, B5


[45757666] A review of the device history record could not be conducted because a lot number was not provided. Manufacturing records are routinely reviewed prior to the release of product to ensure process and product are according the specifications; no findings related to the reported condition were reported. There were no samples returned for this complaint. The complaint shall be reopened if a sample is received. Because the sample has not been received the failure mode could not be confirmed; therefore, the root cause was not identified. As part of the injection molding process the melted resin flows from the machine barrel through the mold manifold and after that filling the mold cavities. During the natural flow of the resin, vent lines are part of the mold design to facilitate the air flow through the injection molding process. Some vent lines could be blocked or inaccessible and that could generate the entrapment of air causing the reported condition. A production notification was sent out to all personnel to ensure that they are aware on the condition reported by the customer and the inspection plan for the valves was moved to tight. If additional information is received warranting further analysis, the investigation will be resumed. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612030-2016-00106
MDR Report Key5494635
Date Received2016-03-11
Date of Report2013-07-25
Date Mfgr Received2013-07-25
Date Added to Maude2016-03-11
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 ContactTHOM MCNAMARA
Manufacturer Street15 HAMPSHIRE ST
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524811
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL
Manufacturer CityTIJUANA
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUCT CTH KIT W/O SOL SFTY-VAC 10FR
Generic NameSUCTION CATHETER
Product CodeOFR
Date Received2016-03-11
Model Number37024
Catalog Number37024
Lot NumberASKU
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKENMEX
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX


Patients

Patient NumberTreatmentOutcomeDate
10 2016-03-11

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