Catalog Number 0684-00-0497 |
Device Problem
Defective Component (2292)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).
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Event Description
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It was reported while opening the package of the balloon catheter, the male connector end appeared warped and torn.The customer utilized another extender tubing.There was no reported injury to the patient.
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Event Description
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It was reported while opening the package of the balloon catheter, the male connector end appeared warped and torn.The customer utilized another extender tubing.There was no reported injury to the patient.
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Manufacturer Narrative
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Device available for eval? from: yes, to: no.The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Reference complaint # (b)(4).
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Search Alerts/Recalls
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