The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.
Based on a review of this information, the following was concluded: the complaint of a damaged probe cover was confirmed but the exact cause remains unknown.
One opened siterite kit packaging and one probe cover were returned for investigation.
The product information on kit label indicated lot: recz0495.
Gel was present within the probe cover.
Inspection of the probe cover revealed a tear 3.
2 cm from the distal end and 2 cm from the edge.
Microscopic observation of the damaged region revealed the tear edges to be stretched and uneven.
The stretched portions of the tear were also observed to be radiating outwards.
The characteristics of the tear suggest an object was likely pressed against the probe cover leading to the tear.
This can occur if the needle guide damages the probe cover during attachment.
A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.
Since the damage was present on the probe cover, the complaint is confirmed but the exact cause remains unknown.
A lot history review (lhr) of recz0495 showed no other similar product complaint(s) from this lot number.
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