ARGYLE 8888750018

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-05-11 for ARGYLE 8888750018 manufactured by Covidien.

Event Text Entries

[74916816] Submit date: 5/11/2017. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[74916817] The customer reported that the gastric tube was bent/crimped.
Patient Sequence No: 1, Text Type: D, B5


[115815284] Seven samples were received for evaluation. A visual inspection was performed and the tubing was found kinked. The reported issue was confirmed. An investigation of the manufacturing process was performed. It was found that the process consists of taking the tube and system and the operator connects them together. The product is then packaged and then placed in a box. The issue was found to not be manufacturing related. However, pieces of tape were found on the tubing samples. A possible root cause can be due to the outside supplier? S packaging process. A formal corrective and preventative action was implemented as a result. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[115815285] The customer reported bent/crimping of the edlich gastric lavage tube.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2017-05200
MDR Report Key6559821
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2017-05-11
Date of Report2017-05-12
Date of Event2017-04-24
Date Mfgr Received2017-05-12
Date Added to Maude2017-05-11
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 ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer Street37 BLVD INSURGENTES A LA P, LA MESA
Manufacturer CityTIJUANA 22225
Manufacturer CountryMX
Manufacturer Postal Code22225
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARGYLE
Generic NameCATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION
Product CodeKDH
Date Received2017-05-11
Returned To Mfg2017-05-12
Model Number8888750018
Catalog Number8888750018
Lot Number170270267
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address37 BLVD INSURGENTES A LA P, LA MESA TIJUANA 22225 MX 22225


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-11

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