WALLACE OOCYTE RECOVERY SYSTEMS ON1733

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-08-10 for WALLACE OOCYTE RECOVERY SYSTEMS ON1733 manufactured by Smiths Medical.

Event Text Entries

[51772407] Additional manufacturer narrative: customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10


[51772408] Distributor reported that a patient experienced severe abdominal pain and heavy bleeding after a puncture. Due to the pain and bleeding, the physician inspected the needle with a magnifying glass and observed irregularities in the bezel. During the puncture, nothing "strange" was noticed. The needles were compared to those of another lot, which did not present the bezel irregularity. Additional information has been requested multiple times, if received, a follow up will be sent.
Patient Sequence No: 1, Text Type: D, B5


[60451826] Potential lots: 2901723 or 2732535. Potential expiration dates: 02/18/2015 or 07/21/2014. Potential manufacturing dates: 01/28/2020 or 06/28/2019. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[60451827] Additional information: according to the reporter, the patient lost no blood externally; however, there was "quite a lot" of blood loss internally, the reporter was unable to determine the exact amount. The reporter stated that the patient spent 5 days in the hospital due to hemoperitoneum; the incident was resolved after the hospital stay.
Patient Sequence No: 1, Text Type: D, B5


[60462328] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[67466238] Two used wallace? Wallace oocyte recovery systems samples were received for investigation. Photographs were also provided for examination. A review of the provided photographs was unable to find defect with the devices. The initial device was received inside a plastic bag on october 21st, 2016. The returned sample was evaluated using a probe microscope; no damage was observed with the device needle tip. A second sample was received inside a plastic bag on december 14th, 2016. The sample was received without the protective sheath to cover the tip. The second returned sample was also evaluated use a probe microscope; the sample was found to be within specification. During functional testing the sample underwent penetration evaluation; the sample was found to be within specification. Investigation determined that both returned samples operated within specification and no fault was found. Please note: initial sample was received on october 21st, 2016. The second sample was received on december 14th, 2016.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2016-01688
MDR Report Key5866007
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2016-08-10
Date of Report2016-07-13
Date of Event2016-07-02
Date Mfgr Received2017-01-20
Date Added to Maude2016-08-10
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 ContactLISA PERZ
Manufacturer Street1265 GREY FOX ROAD
Manufacturer CityST PAUL 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7633833074
Manufacturer G1SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V
Manufacturer StreetCARRETERA MIGUEL ALEM PARQUE INDUSTRIAL MONTERREY
Manufacturer CityAPODACA NL, CP 66603
Manufacturer CountryMX
Manufacturer Postal Code66603
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALLACE OOCYTE RECOVERY SYSTEMS
Generic NameNEEDLE, ASSISTED REPRODUCTION
Product CodeMQE
Date Received2016-08-10
Catalog NumberON1733
Lot Number2732535
Device Expiration Date2019-06-28
OperatorPHYSICIAN
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL
Manufacturer Address1265 GREY FOX RD. ST PAUL MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-08-10

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