(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.Three representative samples was returned for investigation.Based on visual inspect ion, there was no abnormality observed on the samples.Investigation was conducted on the returned samples by inflated and deflated the balloon catheter using colored water and observed that the balloon can be inflated and deflated without any issue.There was no abnormalities or design irregularities observed on the returned samples as per stated by complainants.Leak balloon/cuff may occur due to various reasons such as in contact with sharp or pointed objects or exposure to encrustation which causes leak to the balloon.Other remarks: this will cause balloon not able to stay inflated.However, without actual sample returned for investigation, the actual root cause of this phenomenon could not be determined.In our current standard operating procedure, the products are subj ect ed 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.Leak balloon could happen due to various reasons.However, in the absence of the actual sample and limited information available on this complaint, further investigation could not be conducted and therefore complaint is not confirmed.
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