CURITY MONO-FLO 14FR WO PVPI 6162MF

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 2020-02-27 for CURITY MONO-FLO 14FR WO PVPI 6162MF manufactured by Covidien.

Event Text Entries

[188514822] (b)(4). The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10


[188514843] The customer reported that a (b)(6) male patient underwent a hernia surgery on (b)(6) 2020. At 12 pm, the catheter was indwelled and the balloon was checked and performed without problems. At 9 pm, it was found that the catheter had come out on its own. Upon visual inspection of the catheter tip, the balloon seemed to be partially missing and it was assumed there might be fragments of the balloon inside the patient so the doctor confirmed it with a cystoscope. The result was no piece of balloon/catheter was left inside the patient. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612030-2020-02422
MDR Report Key9764805
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-27
Date of Report2020-02-27
Date of Event2020-02-17
Date Mfgr Received2020-02-18
Date Added to Maude2020-02-27
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO. 125 CUIDAD IND
Manufacturer CityTIJUANA 22500
Manufacturer CountryMX
Manufacturer Postal Code22500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCURITY MONO-FLO 14FR WO PVPI
Generic NameCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
Product CodeKNX
Date Received2020-02-27
Model Number6162MF
Catalog Number6162MF
Lot Number1918346364
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-27

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