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Model Number PS2502 |
Device Problems
Split (2537); Torn Material (3024)
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Patient Problem
Foreign Body In Patient (2687)
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Event Type
Injury
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Event Description
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Fill volume: unk, flow rate: unk, procedure: abdominal surgery, cathplace: unk.The distributor reported an incident of a catheter break that occurred 12 months ago.The soaker was left in situ at the time, as the nurse removing the catheter did not observe that the catheter was incomplete upon removal.Subsequently the patient reported abdominal pain.The patient was not harmed but reported to have suffered pain for twelve months.When the patient went in for another procedure the catheter remnant was surgically removed using local anesthetic.
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Manufacturer Narrative
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Method: a portion of the catheter segment was returned for analysis.A visual inspection was performed on the suspect device.The lot number of the suspect device was unavailable, therefore, a review of the device history record (dhr) could not be performed.Results: at this time the suspect device is undergoing evaluation and testing.Results will be provided when evaluation has been completed.Conclusions: our investigation and evaluation is currently in progress, once completed, a follow-up report will be submitted.Information from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend information, or other analysis as appropriate.
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Search Alerts/Recalls
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