3ML SMARTIP MED-PREP CANNULA 8881540133

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 2019-10-08 for 3ML SMARTIP MED-PREP CANNULA 8881540133 manufactured by Covidien.

Event Text Entries

[164659400] 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


[164659401] The customer reported that when drawing up the medication, the medication squirts out from the holes lower on the blunt tip. Additional information received from the customer stated that when the solution in the syringe is being pushed out, there are tiny little streams that come out of the syringe other than from the tip of the cannula. There were two tiny dots noted that spew out the liquid. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1017768-2019-00696
MDR Report Key9169835
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-10-08
Date of Report2019-10-08
Date of Event2019-09-24
Date Mfgr Received2019-09-24
Date Added to Maude2019-10-08
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 Street2010 EAST INTERNATIONAL SPEEDW
Manufacturer CityDELAND FL 32724
Manufacturer CountryUS
Manufacturer Postal Code32724
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3ML SMARTIP MED-PREP CANNULA
Generic NameCANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGEA
Date Received2019-10-08
Model Number8881540133
Catalog Number8881540133
Lot Number912300
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2010 EAST INTERNATIONAL SPEEDW DELAND FL 32724 US 32724


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-08

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