This issue occurred during a procedure where the user (radiology tech) did not see that the bag did not have the pinch clamp and when she went to close the bag, abdominal fluid sprayed on her face.The ifu requires you to close the clamp on the bag prior to detaching the tubing assembly.The issue does not affect the performance of the product but could be a safety issue for the user.The used fluid collection bag was discarded by the facility.The facility indicated that the other fluid collection bag in the kit did not have the clamp on the it and that they opened two other large volume paracentesis kits and the fluid collection bags in the kit did not have the clamp.Each kit has 2 fluid collection bags.The facility sent pictures of 2 bags without the pinch clamp and returned those 2 bags to gi supply.The returned fluid collection bags were received on (b)(4) 2016.The missing clamp on each of the returned fluid collection bag was verified to be missing.The facility indicated they used and discarded the other 2 large volume paracentesis kits and therefore did not return the kits.From the lot (lot 61442434), 13 random kits were inspected by gi supply during incoming inspection and this defect was not observed.Another 3 kits were randomly pulled, opened and inspected upon receipt of the complaint and this defect was not observed.Due to the packaging, the components cannot be visually inspected without opening the sterile package.No other complaints have been received.This kit was first shipped to customers on 03 november 2015.
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