It was reported that in the picu, the doctor struggled to place the introducer needle into the (b)(6) female patient's jugular, stating it was too long for the procedure.As a result, he attempted to use a blue gelco needle, however, the guide wire would not pass through it.It is unknown if another attempt was tried on the patient with burn wounds.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
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Qn#(b)(4).Device evaluation: the reported complaint that the introducer needle was too long for the procedure and the guide wire would not pass through a non- arrow needle used during the second attempt could not be confirmed.The customer returned one guide wire and one introducer needle in an opened kit.Visual examination revealed two kinks near the distal end of the guide wire and the rest appeared typical.No damage was observed with the returned needle.Microscopic examination revealed three kinks at the distal end of the guide wire and two of these had offset coils.Microscopic examination also revealed that both weld were full and spherical and that no damage was observed with the returned needle.A manual tug test was performed on both ends of the wire and both welds were intact.The kinks in the wire were measured at 7 mm, 1.8 cm and 2.4 cm from the distal weld.The length of the guide wire measured 352 mm and the outside diameter (od) measured 0.613 mm both of which do not meet specification for the guide wire packaged in the reported kit (length: 444- 456 mm & od:.430-.470 mm).The returned needle with a blue hub is also not from the reported kit.Functional testing was performed with the returned components and the guide wire passed through the needle without resistance other remarks: which does not match what the customer reported.The investigation findings revealed that both returned components are not from the reported kit and do not match the reported complaint of the guide wire not passing through the introducer needle.A device history record review was performed on the guide wire from the reported kit with no relevant findings.Therefore, the cause of this complaint could not be determined.No further action will be taken.
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