Model Number 384516 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Event Description
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Line trimmed to premeasured insertion length of 15 cm pre procedure.Line inserted on first attempt, upon removal of introducer cap the line and wire retracted and line noted to be fractured with 9.5 cm outside body and 5.5 cm remaining in patient.Required patient transport to (b)(6) hospital for medical intervention to retrieve fractured picc line (removal via catheterization procedure) line segment removed successfully with no known harm to patient no accessory devices were used for placement.
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Event Description
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Line trimmed to premeasured insertion length of 15 cm pre procedure.Line inserted on first attempt, upon removal of introducer cap the line and wire retracted and line noted to be fractured with 9.5 cm outside body and 5.5 cm remaining in patient.Required patient transport to seattle children¿s hospital for medical intervention to retrieve fractured picc line (removal via catheterization procedure) line segment removed successfully with no known harm to patient no accessory devices were used for placement.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications, there has been no sample returned for this complaint.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and establishing a definite root cause and corrective action is not possible.If the samples are returned at a future date, these complaints will be reopened for further evaluation at that time.
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Event Description
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Line trimmed to premeasured insertion length of 15 cm pre procedure.Line inserted on first attempt, upon removal of introducer cap the line and wire retracted and line noted to be fractured with 9.5 cm outside body and 5.5 cm remaining in patient.Required patient transport to (b)(6) hospital for medical intervention to retrieve fractured picc line (removal via catheterization procedure).Line segment removed successfully with no known harm to patient.No accessory devices were used for placement.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no similar concerns were found.A section of a catheter measuring approximately 6 cm was returned for review.Per the event description from the customer, the catheter tubing broke upon removal.Upon examination of the ends of the returned catheter section, both ends were observed to have straight edges as though the tubing had been cut by a sharp instrument.There were no jagged edges which would be indicative of a tensile force applied to the catheter.The most probable cause for the reported issue was most likely related to an event within the user environment.There have been no other similar complaints regarding the reported issue with this lot number.Since the reported issue was most likely related to an event within the user environment and not a manufacturing error, no corrective action will be taken at this time.
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Search Alerts/Recalls
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