BLUNTPORT PLUS 179775P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-05-15 for BLUNTPORT PLUS 179775P manufactured by Davis & Geck Caribe Ltd.

Event Text Entries

[75108885]
Patient Sequence No: 1, Text Type: N, H10


[75108886] According to the reporter: during the procedure, upon opening package, air valve disengaged from obturator. The procedure was completed with another device. The status of the patient: no problem
Patient Sequence No: 1, Text Type: D, B5


[77635099] Post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted; the port seal was received without the cannula and the insufflation port was disengaged. The condition of the device precludes functional testing. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. Replication of the disengaged valve may occur when mishandled during clinical application. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. 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


[121043718] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612501-2017-05487
MDR Report Key6566316
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-05-15
Date of Report2017-05-22
Date of Event2017-04-17
Date Mfgr Received2017-05-22
Date Added to Maude2017-05-15
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 ContactSHARON MURPHY
Manufacturer Street60 MIDDLETOWN AVENUE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925267
Manufacturer G1DAVIS & GECK CARIBE LTD
Manufacturer StreetZONA FRANCA DE SAN ISIDRO
Manufacturer CitySANTO DOMINGO 0101
Manufacturer CountryDO
Manufacturer Postal Code0101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBLUNTPORT PLUS
Generic NameGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGDH
Date Received2017-05-15
Returned To Mfg2017-04-24
Model Number179775P
Catalog Number179775P
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDAVIS & GECK CARIBE LTD
Manufacturer AddressZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101


Patients

Patient NumberTreatmentOutcomeDate
10 2017-05-15

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