Model Number M00202019579P0 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that the product is available for investigation, it should be returned to intervascular for examination.A review of the complaint device history records, indicated that the patch was processed and inspected according to established procedures and was therefore released following acceptable quality inspections and tests including a 100% visual inspection of the patch.Specifically, no anomaly was evidenced in the collagen coating records.A retention sample from same lot and coated on the same day and under the same conditions as the involved device was identified.A visual inspection by the qa department will be performed.The review of post-marketing historical data indicated that no other similar complaint was reported for the same lot number.The investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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Event Description
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The event occurred during preparation for a procedure.Upon opening the package, the patch was found to have a "sticky brown gunk" down the midline.There was enough of it to contaminate the tech's gloves from touching the patch.A replacement device was used to complete the procedure.No patient involvement.
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Manufacturer Narrative
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The involved product was returned to intervascular and was visually inspected by our quality assurance (qa) supervisor and two quality control (qc) technicians.The deficiency reported was confirmed and identified as an excess of collagen.One retention sample from same lot and coated on the same day and under the same conditions as the involved device was visually inspected by our qa supervisor and the two same qc technicians.No anomaly was found.The conducted investigation suggests that the issue was an isolated event probably related to human errors during manufacturing steps.It has been decided to raise awareness of this type of defect among all manufacturing operators concerned, or likely to be concerned.
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Search Alerts/Recalls
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