After further review of additional information received the following sections d10, g4, g7, h2, h3 and h6 have been updated according.As reported, the packaging of 125cm multipurpose (mp) a1 tempo angiographic catheter that includes the sterile packaging was damaged.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).The outer product box and the inner sterile pouch was cracked.The integrity of the sterile pouch was compromised.The damage was noted after it had been received and stored in the lab prior to using.The actual product was not damaged.The product was not used in patient.The device and a picture were both received for analysis.During the picture evaluation, a linear cut located almost in the middle of the tyvek that runs along the package could be noticed.No other anomalies of the product can be noticed on the attached picture.One non-sterile unit of a tempo catheter (cath tempo 4f mp a1 (i) 125cm) was received for analysis.During the visual inspection, the device was received inside the inner pouch.On the back of the pouch, a transversal cut was noted on the middle section of some portions of the pouch.No other damages or anomalies were observed on the unit.Per microscopic analysis, a thin and precise cut was observed on the pouch.This type of damage is commonly related to the interaction of the material with a sharp object.A product history record (phr) review of lot 17892498 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿packaging/pouch/box ¿ frayed/split/torn - outer box¿ was not confirmed since no outer box was returned for analysis.The reported events by the customer as ¿packaging/pouch/box ¿ frayed/split/torn - inner package¿ and ¿packaging/pouch/box - compromised sterility¿ were confirmed since a cut was observed on the back of the inner pouch.Amplified images were taken, and it was observed that a thin and precise cut was present.This type of damage is related to the interaction of the material with a sharp object.Shipping/handling factors might have contributed to the reported conditions.As per the precautions in the instructions for use (ifu), which is not intended as a mitigation, ¿store in cool, dark, dry place.Do not use if the package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54°c (130°f) may damage the catheter.¿ neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.
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