The device history record (dhr) for the reported lot was reviewed and showed that manufacturing and product inspection was performed as per applicable procedures and validated process.One used decontaminated sample outside of its original packaging was received for evaluation.The sample was visually inspected; the catheter showed signs of use such as residues of a yellow substance and the tube was broken, the stabilizer butterfly is detached and there is also adhesive residue on the tube.Therefore, the condition reported by the customer was confirmed.The root cause could be associated to an omission gap error by personnel due to attention management by the operator during the solvent application process.A quality alert was issued to the focus factory personnel, summarizing the reported event to heighten awareness and prevent the recurrence of the reported issue during the manufacturing process.
|