Model Number 383591 |
Device Problem
Break (1069)
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Patient Problems
Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)
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Event Date 02/03/2022 |
Event Type
Injury
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Event Description
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It was reported while using bd nexiva¿ diffusics¿ closed iv catheter system 22 ga 1.00 in catheter separated from hub in patient's arm upon removal.There was no report of patient impact.The following information was provided by the initial reporter: date of event: (b)(6) 2022.# of occurrences: 1.Material #383591, batch #1209927.Report of what occurred: at insertion of a bd nexiva diffusics 22 gauge 1 inch catheter into the left cephalic ac vein bleeding was noted at the puncture site.The iv hub was removed as bleeding at the insertion site is abnormal.Upon removal of the hub there was no catheter sheath attached to the hub.X-ray was preformed and a 2.9 cm linear radiopaque foreign body of the lateral aspect of the antecubital fossa was seen and consistent with a retained iv cannula.Patient was transported to the emergency department and the foreign body was removed at the bedside.
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Manufacturer Narrative
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A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 16-mar-2022.H.6.Investigation: our quality engineer inspected the 2 samples submitted for evaluation.The reported issue of catheter broke / separated was confirmed but the issue of needle pulled out of the hub was not confirmed after examination of the samples.During the examination of the samples one of the samples was found to have a cut in the catheter tubing, most likely cause by the needle.The defect of needle pulled out of the hub was not observed because the sample was returned used with no needle.Bd determined that the cause of the catheter broke / separated failure was most likely associated to improper use of the device.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.Without the complete device assembly, we were unable to determine a root cause for the needle pulled out of the hub defect.It is necessary for all parts of the sample assembly to be returned since they could have evidence that may help determine the root causes of the failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Event Description
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It was reported while using bd nexiva¿ diffusics¿ closed iv catheter system 22 ga 1.00 in catheter separated from hub in patient's arm upon removal.There was no report of patient impact.The following information was provided by the initial reporter: date of event- 03 feb 2022.# of occurrences - 1.Material #383591 - batch #1209927.Report of what occurred: at insertion of a bd nexiva diffusics 22 gauge 1 inch catheter into the left cephalic ac vein bleeding was noted at the puncture site.The iv hub was removed as bleeding at the insertion site is abnormal.Upon removal of the hub there was no catheter sheath attached to the hub.X-ray was preformed and a 2.9 cm linear radiopaque foreign body of the lateral aspect of the antecubital fossa was seen and consistent with a retained iv cannula.Patient was transported to the emergency department and the foreign body was removed at the bedside.
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Search Alerts/Recalls
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