WALLACE OOCYTE RECOVERY SYSTEMS N/A 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 2016-06-23 for WALLACE OOCYTE RECOVERY SYSTEMS N/A ON1733 manufactured by Smiths Medical International, Ltd.

Event Text Entries

[48049276] 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


[48049277] Distributor reported that the physician observed rough needle tips during oocyte recovery procedures. This was observed 15 times out of approximately 50 procedures. The patient's experienced internal bleeding, up to 600 mls, as well as 100-150 ml externally. As a result of the internal bleeding, all patients received hemostatic therapy. Some patient's required surgical treatment, including suturing of the ovary and puncture site. All of the patients recovered. Individual patient details were not provided.
Patient Sequence No: 1, Text Type: D, B5


[57827401] The reported wallace oocyte recovery set 17g, 10/ca used devices were destroyed. There were images provided by the customer, and it was observed that the tips of the needles were damaged. The complaints were confirmed the needle tip was observed to be damaged. Mfr# clarification: new registration number 3012307300 (b)(4) has been received, however, this initial mdr was filed under the prior registration number 2183502 (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[60666313] Thirty unused wallace? Oocyte recovery systems were returned for evaluation. Visual inspection found that the needle protector were in good condition to assure safe handling. Microscopic visual inspection found no damage and that the devices were found within specification. Functional testing involved a penetration test and all samples were found within specification. Retained samples from a different lot were visually and functionally tested and were found within specification. A gage repeatability and reproducibility study was performed on the part and all personnel detected damaged devices appropriately. Photos of the actual devices were provided by the customer and it was observed that the tips of the needle were damaged. Based on the evidence, the root cause was unable to be determined and all returned and retained devices were found within specification. The complaint was confirmed based on the observed photographic evidence. There was no evidence found to suggest the event was caused from an intrinsic defect in the product.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2016-01235
MDR Report Key5745425
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2016-06-23
Date of Report2016-05-25
Date Mfgr Received2016-10-25
Device Manufacturer Date2015-07-17
Date Added to Maude2016-06-23
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 ContactMICHELE SELIGA
Manufacturer Street1265 GREY FOX ROAD
Manufacturer CityST PAUL 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7633833052
Manufacturer G1SMITHS MEDICAL INTERNATIONAL, LTD
Manufacturer StreetBOUNDARY ROAD
Manufacturer CityHYTHE, KENT CT216JL
Manufacturer CountryUK
Manufacturer Postal CodeCT21 6JL
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWALLACE OOCYTE RECOVERY SYSTEMS
Generic NameNEEDLE, ASSISTED REPRODUCTION
Product CodeMQE
Date Received2016-06-23
Model NumberN/A
Catalog NumberON1733
Lot Number3003611
OperatorPHYSICIAN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL INTERNATIONAL, LTD
Manufacturer AddressMARK UPTON BOUNDARY ROAD HYTHE, KENT CT216JL UK CT21 6JL


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-06-23

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