It was reported that bd insyte autog bc blu 22ga x 1.0in had foreign matter the following information was provided by the initial reporter: it was reported by customer that the item is #382523, lot #3192172 22g insyte auto guard with blood control catheters.I have stumbled upon probably 45 out of the 50 in the box that are leaking some type of greasy substance near the spring inside the needle retractor.Upon opening them, this substance gets all over your hands/gloves.I feel this is a pretty substantial patient safety and infection control problem.Some of the catheters are leaking so much of this substance that you can see the grease marks on the outside of the package.Also, not sure if it's related to this leaking substance, but this also jams up the button to retract the needle therefore the needle has a hard time retracting into the device posing another safety/infection risk of having an exposed/nonretractable used needle.I have several pictures of some of them we opened for demonstration purposes as well as a video of the jammed needle retractor button if you would like me to send those over as well.I have about 8 boxes of these same lot # catheters that i don't feel comfortable using on patients due to these issues, so i am not sure what to do about this.Verbatim: rcc received a complaint via email.Email(s) attached.The item is #382523, lot #3192172 22g insyte auto guard with blood control catheters.I have stumbled upon probably 45 out of the 50 in the box that are leaking some type of greasy substance near the spring inside the needle retractor.Upon opening them, this substance gets all over your hands/gloves.I feel this is a pretty substantial patient safety and infection control problem.Some of the catheters are leaking so much of this substance that you can see the grease marks on the outside of the package.Also, not sure if it's related to this leaking substance, but this also jams up the button to retract the needle therefore the needle has a hard time retracting into the device posing another safety/infection risk of having an exposed/nonretractable used needle.I have several pictures of some of them we opened for demonstration purposes as well as a video of the jammed needle retractor button if you would like me to send those over as well.I have about 8 boxes of these same lot # catheters that i don't feel comfortable using on patients due to these issues, so i am not sure what to do about this.
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Additional information: date of event provided by customer.Updated.Investigation results: the complaint of excess gel was confirmed and the cause appeared to be manufacturing related.The provided photographs and returned samples exhibited excess gel on the sealed 22g insyte autoguard units.Although not confirmed with the representative samples, the reported needle retraction issues may have been a cascading issue due to excess gel.The appropriate manufacturing personnel were notified of this complaint.A device history record review showed no non-conformances associated with this issue during the production of the reported production batches.Investigation conclusion(s): the complaint of ¿foreign matter¿ was confirmed.Excess gel, which is a non-foreign matter, was observed in the provided photographs and on the returned samples.Probable root cause conclusion(s): manufacturing.
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