Date received by manufacturer: bd was initially made aware of this complaint on 2021-06-25.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional investigational information was later received on 2021-09-10 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.Investigation summary: one sample with open packaging was received by our quality team for evaluation.The sample was subjected to visual inspection to check for catheter damage.From the returned sample, the needle pierced through the catheter tip was observed.No cannula bevel damage was observed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the verbatim, ¿the catheter had been checked prior to use, and no problems were noted¿, this defect occurred outside of the manufacturing facility.Needle pierced through the catheter can also occur during insertion when the product is manipulated.As the sample was opened and used, the actual root cause could not be established.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
|
It was reported that insyte pnk 20ga x 1.16in needle went through the catheter.The following information was provided by the initial reporter: patient came in for a blood test.The patient had thicker/harder skin.When penetrating the skin, the catheter deformed, turned over and only the needle was inserted.This caused the patient pain.The catheter had been checked prior to use, and no problems were noted.Local pain on puncture.From investigation: "one sample with open packaging was received by our quality team for evaluation.The sample was subjected to visual inspection to check for catheter damage.From the returned sample, the needle pierced through the catheter tip was observed.No cannula bevel damage was observed.".
|