Model Number H7493941820300 |
Device Problems
Contamination (1120); Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that sterility was compromised.A 3.00 x 20mm synergy xd drug-eluting stent was selected for use.It was noted that the product was properly sealed in the box, but the sterile packaging on the inside the box was opened and seemed to be unsterile.
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Manufacturer Narrative
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B3 date of event: used the first day of the month of bsc aware date since event date was not provided.
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Event Description
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It was reported that sterility was compromised.A 3.00 x 20mm synergy xd drug-eluting stent was selected for use.It was noted that the product was properly sealed in the box, but the sterile packaging on the inside the box was opened and seemed to be unsterile.
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Manufacturer Narrative
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B3 date of event: used the first day of the month of bsc aware date since event date was not provided.Device evaluated by mfr: a 3.00 x 20mm synergy xd catheter was returned for analysis.A visual and microscopic analysis was performed on the returned device.Received was the device inside its box packaging.An examination of the outer box found that the blue closure strip was peeled open.The top corners of the outer box were creased and there was handwriting in black ink on the outside of the box.An examination of the inner pouch confirmed that the pouch had been torn open.The device was inside the pouch.An examination of the pouch found clear evidence of the pouch seals.The device was removed and examined.There was no evidence of any device use.No damages were observed along the entire length of the device.A microscopic examination of the inner pouch identified that although the pouch was torn open, there was clear evidence of the pouch seals.This confirms that the pouch was sealed.
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Search Alerts/Recalls
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