Catalog Number ON1733 |
Device Problem
Physical Property Issue (3008)
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Patient Problems
Abdominal Pain (1685); Blood Loss (2597)
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Event Date 07/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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).
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Event Description
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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.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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