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Model Number N/A |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Code Available (3191)
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Event Date 07/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.
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Event Description
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Per the mw(b)(4), reported through the fda voluntary event reporting process, the manufacturer was informed that the guide wire was not removed after chest tube placement.The reporter alleged that the "tag that says "remove dilator after chest tube insertion" is not very noticeable or understandable." it was further reported to the manufacturer in response to inquiry's that: the drainage being performed was pneumothorax, no unintended sections of the device remained in the patient, an additional procedure was performed, the complained device was in place for 1 day, the chest tube was replaced with a different device and remained in for 2 days, the patient is doing well and no adverse events occurred due to this event.
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Manufacturer Narrative
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Investigation - evaluation: a review of the device history record, manufacturing instructions, quality control, and specifications of the returned device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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Search Alerts/Recalls
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