Catalog Number AN-05505 |
Device Problems
Bent (1059); Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The facility has communicated that the device is not available for evaluation.Teleflex will continue to monitor and trend related events.
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Event Description
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While placing the epidural needle into a morbidly obese patient, the patient was fine but the physician was concerned that he did not realize that the needle was broken until he removed it from the patient's back and had a bit of a hard time getting it out.The epidural was placed using another epidural needle.The physician felt that the second 5 inch needle bent more than usual.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural needle with no relevant findings.A corrective action is not required at this time as the potential cause of the needle bending could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the needle bending could not be determined based upon the information provided and without a sample.
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Event Description
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While placing the epidural needle into a morbidly obese patient the patient was fine but the physician was concerned that he did not realize that the needle was broken until he removed it from the patient's back and had a bit of a hard time getting it out.The epidural was placed using another epidural needle.The physician felt that the second 5 inch needle bent more than usual.The patient's condition was reported as fine.
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Search Alerts/Recalls
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