Model Number JSACTI8004S |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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The incision for implanting the port had been made when it was noted that the introducer size is smaller than the catheter.When the doctor attempted insertion the procedure could not be completed.Another kit from the same lot was opened but the same issue was encountered.As a result the procedure to implant the port was cancelled.
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Manufacturer Narrative
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No devices were returned.Photographs and video provided confirm the complaint.A supplier corrective action request was issued to the contract manufacturer.The contract manufacturer's investigation revealed the root cause of this issue was mislabeling of the devices upon receipt from their supplier, as well as a mixing of components while on the production floor.It was also noted that some partial lots were delivered to the production floor prior to completion of the lot.As a result, packaging and inspection procedures have been revised by the contract manufacturer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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