Although no faulty sample was returned, the documentation of the incident shows obvious signs of bad positioning/movement of the catheter which probably caused cardiac tamponade.The customer claimed that the catheter was difficult to be seen via x-ray.We therefore checked our documentation regarding radiopacity testing: radiopacity checks are done with each batch of catheter tubes extruded.They are done according to the internal test procedure pm 69 "determination of radiopacity".The tubes used to manufacture this batch were conform to this test (0,64 mm al).Cardiac tamponade is a rare complication of piccs placed in neonates.One reason for failure is the catheter tip inserted too far into the neonate's heart.The customer did not provide any further details about the catheter's tip position or the circumstances of catheter use.Having reviewed the batch history records of batch no.101219go, which consisted of 1700 ea, we found no deviation from specification.The batch was released.This is the second complaint received for batch no.101219go and the second complaint received for code 1261.207 about cardiac tamponade within the last 3 years.To alert the user to possible complications, each catheter is placed in a sealed blister and covered with a warning leaflet stating: " warning: failing to follow the precautions of use can cause cardiac tamponade or other severe complications." this leaflet has to be removed from the product before the catheter can be taken out of the primary packaging.Furthermore, we warn in the product's ifu: "the using physician should be familiar with and undertake all standard precautions to avoid problems or complications associated with the introduction and use of central venous catheters.Complications associated with percutaneous catheter placement include vessel wall perforation, cardiac tamponade, haemorrhage, air embolism, catheter embolism, nerve lesions, infections, thrombosis,.[[?]] precautions: the catheter tip must not be advanced into the heart (right atrium).The location of the catheter within the heart may cause cardiac tamponade, or cardiac arrhythmias.It is necessary to make checks of the catheter tip position at regular intervals throughout the usage of the catheter." it seems as if the users did not do the tip position checks at regular intervals.We strongly recommend to retrain the users in this hospital regarding premicath catheter handling in compliance with the product's ifu.Each catheter is leak and flow tested during production.The tensile force of the catheter components is randomly checked.Visual tests are carried out for product/component presence, the presence in cavities and the integrity of the product seal.Radiopacity tests are done with each catheter tube batch after extrusion.Catheter tube code 6g35961012, batch no.8065071 was used.Radiopacity tests complied with the specification.
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