Model Number 400273 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 07/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that kit perisafe 18ga 3-1/2in weiss catheter broke during use.The following information was provided by the initial reporter: when the catheter is inserted into the epidural space and without performing any maneuver, it breaks, leaving about 5 cm of the catheter in the epidural space.For the moment, the patient remains asymptomatic and under extreme surveillance by neurosurgery.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/17/2020.H.6.Investigation: one epidural catheter component was received on bd juncos.Upon visual inspection, it was observed that the catheter was broken; therefore the investigation could be verified.A device history record could not be evaluated as the lot number is unknown.As part of the inspection process of catheter, pull test is performed as part of release criteria.A root cause could not be determined due to no lot number.The supplier that manufactures the catheter has been notified of the complaint.H3 other text : see h.10.
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Event Description
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It was reported that kit perisafe 18ga 3-1/2in weiss catheter broke during use.The following information was provided by the initial reporter: when the catheter is inserted into the epidural space and without performing any maneuver, it breaks, leaving about 5 cm of the catheter in the epidural space.For the moment, the patient remains asymptomatic and under extreme surveillance by neurosurgery.
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Search Alerts/Recalls
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