PALINDROME UNK DY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-30 for PALINDROME UNK DY manufactured by Covidien Mfg Solutions S.a..

Event Text Entries

[76154721] Submit date: 2017/may/30. An investigation is currently underway; upon completion the results will be forwarded. 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


[76154722] It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states the patient returned to the facility for dialysis in the eighth week after insertion of the catheter and the nurse found the catheter was freely moving in and out of the entry site.
Patient Sequence No: 1, Text Type: D, B5


[130363812] An investigation was performed. Since no lot number was identified, a manufacturing device history record (dhr) review or product/process change review for the involved lot number could not be performed. However, all dhrs are reviewed for accuracy prior to product release. The actual sample involved in the reported incident was not returned for evaluation. No additional information, pictures or videos were received. Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation. No probable cause was found since a sample, picture or video were not received for testing; therefore the reported issue is not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations. This complaint will be used for tracking and trending purposes. The line was discarded by the patient/renal nurses since it is a single use item. No photos available. The cuff was completely out with no signs of fibrosis to the patient's tissue after 6 weeks sutured. No tract infections and sutures removed at 6 weeks. Female, (b)(6) yrs, right jugular line - 23cms, line slipped out in the 8th week. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[130363813] The customer states the patient returned to the facility for dialysis in the eighth week after insertion of the catheter and the nurse found the catheter was freely moving in and out of the entry site.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3009211636-2017-05144
MDR Report Key6597622
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-05-30
Date of Report2017-05-03
Date Mfgr Received2017-05-03
Date Added to Maude2017-05-30
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 MFG SOLUTIONS S.A.
Manufacturer StreetEDIFICIO B20, CALLE #2
Manufacturer CityALAJUELA 0101
Manufacturer Postal Code0101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePALINDROME
Generic NameCATHETER, PERITONEAL DIALYSIS, SINGLE USE
Product CodeFKO
Date Received2017-05-30
Model NumberUNK DY
Catalog NumberUNK DY
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG SOLUTIONS S.A.
Manufacturer AddressEDIFICIO B20, CALLE #2 ALAJUELA 0101 0101


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-30

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