It was reported that upon attempting to start a iv, when threading the needle, the metal needle perforated the plastic tubing at the end of the hub.This required the infant to require multiple iv attempts.This equipment failure resulted in two unsuccessful iv attempts, causing skin puncture to the baby unnecessarily.
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There were seven (7) samples sent in (one (1) used and six (6) unused) and three (3) photos provided for investigation.The unused samples were received with the assemblies fully seated and were manually advanced into a vein pad, clicked and locked out as designed with no evidence of cannula tips protruding beyond the guard nose components.The three (3) photos displayed a 24g protectiv device with evidence of catheter shear.Unfortunately, these photos did not include magnified closed up views of the device for evidence of cannula or catheter bevel tip irregularities, mechanical witness marks or manufacturing damage.All seven (7) samples displayed no evidence of cannula or catheter bevel tip irregularities, bent cannula, damage to locking mechanism or catheter hub, catheter severance and eyelet-to-tube tears.Pressure testing, using a water filled syringe, of the unused samples indicated no evidence of leakage in the catheter tubing.The used sample displayed normal flash in the flashback chamber with evidence of a puncture in the tubing where the tube meets the hub nose.The puncture was consistent with the ?j?-shape profile of the cannula, resulting in catheter shear.Based on device analysis, the complaints were determined to be due to a variation in insertion technique.Dhr review was done, no issues related to the original complaint were found.
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