Model Number 405211 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Headache (1880)
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Event Date 06/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that while using the bd¿ long length spinal needle with quincke bevel a csf leak occured in a patient.The following was received from the initial reporter: now i have a question on another topic.Last week, on the occasion of an epidural steroid infiltration, we had a complication of a csf leak in a patient.We use the bd quincke needle for this.In the guidelines, you always read about "atraumatic" needles, for bd, for example, the whitecare.When i look at the needles, however, i would assume that this is a needle exclusively for csf puncture.Can these needles also be used for epidural infiltration? the opening in front of the tip does not seem suitable to me.Or are there other "atraumatic" needles for epidural infiltrations? update 20jun2023: 1.Was there any patient impact/harm due to the csf leak? yes, a csf loss syndrome, the patient had a headache, could only lie down and could not go to work for 2 weeks.2.Has a special treatment/safety measure been implemented? yes, a blood patch epidural.Thank you in advance for your support.
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Manufacturer Narrative
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Investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
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Event Description
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It was reported that while using the bd¿ long length spinal needle with quincke bevel a csf leak occured in a patient.The following was received from the initial reporter: now i have a question on another topic.Last week, on the occasion of an epidural steroid infiltration, we had a complication of a csf leak in a patient.We use the bd quincke needle for this.In the guidelines, you always read about "atraumatic" needles, for bd, for example, the whitecare.When i look at the needles, however, i would assume that this is a needle exclusively for csf puncture.Can these needles also be used for epidural infiltration? the opening in front of the tip does not seem suitable to me.Or are there other "atraumatic" needles for epidural infiltrations? update 20jun2023: 1.Was there any patient impact/harm due to the csf leak? yes, a csf loss syndrome, the patient had a headache, could only lie down and could not go to work for 2 weeks.2.Has a special treatment/safety measure been implemented? yes, a blood patch epidural.Thank you in advance for your support.
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Search Alerts/Recalls
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