Model Number IPN046311 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Spinal Column Injury (2081)
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Event Date 03/11/2022 |
Event Type
Injury
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Event Description
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Involved a female patient who was in maternity room.The lor syringe does not identify the loss of resistance during the procedure of insertion of the epidural catheter.With physiological saline, the syringe stiffened and resistance occured leading to a dural breach.Additional information: patient went home.A blood patch was applied and analgesics paracetamol plus ibuprofene.The device is not available for investigation.
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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Involved a female patient who was in maternity room.The lor syringe does not identify the loss of resistance during the procedure of insertion of the epidural catheter.With physiological saline, the syringe stiffened and resistance occured leading to a dural breach.Additional information: patient went home.A blood patch was applied and analgesics paracetamol plus ibuprofen.The device is not available for investigation.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the lor syringe with no relevant findings.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.There have been no material changes for this part during the last two years that could have led to this complaint.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.
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Search Alerts/Recalls
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