Qn#(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed qa inspection test.An actual sample was received for investigation.It was reported that balloon of the foley was broken 1-2 days after being inserted to the patient.Visual examination was conducted on the returned sample, and it was observed that the catheter was broken into 2 parts (funnel and shaft).Besides that , no other abnormalities observed.The balloon was still intact and in good condition.Both the catheter shaft and funnel were examined using dino-lite to analyze the damaged area and torn edges.Based on observation, the torn shaft surface was jagged and uneven.Review on the funnel portion reveals same cutting edges in which suggesting that the tube was once well attached to the funnel.Further investigation, the returned sample was inflated by using hypodermic needle on 12ml luer syringe and observed the balloon was able to inflate properly without having any issue.Attempt to deflate the balloon also observed no difficulties during removing the hypodermic needle from the lumen.Catheter broke may occur due to various reasons such as catheter was in contact with sharp or pointed object that may deteriorate the catheter.Nevertheless, as part of our initiative, positive released test was conducted at injection molding process.A maximum of 8 pieces of catheter from each batch were tested using weight load during start and stop of injection molding process.This is to test the bonding strength between the funnel and tube.Batches that pass this test are subjected for release.Besides that, in our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheter with defective balloon will be culled out during this process.In summary, based on the investigation conducted, the balloon of the returned sample did not exhibit any sign of damage and failure to perform as intended.Therefore, this complaint could not be confirmed.
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