Model Number 821731C |
Device Problem
Material Separation (1562)
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Patient Problems
Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Awaiting part to be returned for investigation.Customer shipped the part on the 09th may 2020.Justification for not providing below information and applicable sections: patient information - no patient injury reported, device malfunction occurred.Relevant tests / laboratory data - this section is not applicable as no patient injury occurred.Other relevant history, including preexisting medical conditions: this section is not applicable as no patient injury occurred.Suspect products - not applicable.Serial/lot # - information not available from customer.Expiration date # - information not available from customer.Unique identifier (udi) # - information not available at the time of this report.If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.If explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable.Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient.Concomitant medical products and therapy dates (excluding treatment of event) - this section is not applicable to this type of device.For use by user facility / importer - not applicable as we are not a facility or importer of device.If ind, give protocol # - this section is not applicable as the medical device is not ind.Adverse event terms - this section is not applicable to medical devices.Device manufacturing date - information not available at the time of this report.If remedial action initiated , check type - this section is not applicable as no remedial action was initiated.If action reported to fda under 21 usc 360i (f), list correction / removal reporting number - this section is not applicable as there was no action reported under 21usc 360i(f).
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Event Description
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While changing the collection bag on the codman eds iii drainage system, the luer lock flew off.
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Event Description
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While changing the collection bag on the codman eds iii drainage system, the luer lock flew off.
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Manufacturer Narrative
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Update 11 june 2020 (follow up 001).Part has been received at lab for decontamination as of the 14th may 2020 awaiting update on when the product will be returned for investigation.
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Manufacturer Narrative
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Update 05 aug 2020 (follow up 003).Due to engineering working remotely, the product has not been evaluated todate.Contacted engineering for an update on to when this may be completed.
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Event Description
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While changing the collection bag on the codman eds iii drainage system, the luer lock flew off.No injury to patient.
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Manufacturer Narrative
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Update 07 july 2020 (follow up 002).16-jun-20 confirmation received that product was shipped back to natus, tracking number showed that product was received in on 02 june 2020.06-jul-20: due to engineering working remotely, the product has not been evaluated.Return date to office to be confirmed.
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Event Description
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While changing the collection bag on the codman eds iii drainage system, the luer lock flew off.
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Manufacturer Narrative
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18 december 2020: ref to natus complaint # (b)(4) (follow up 004).Investigation and findings: per engineering evaluation: "root cause/failure investigation: the luer lock collar that is used to tighten the bag connection was missing.The customer complained it "flew off" when the bag was being changed.The collar was not available to inspect.No other parts appeared damaged, user was able to still attach the bag to the buretrol line using the tapered connection.It's possible users are turning the luer lock collar the wrong way accidentally over tightening it.Depot repair confirmed failure, the unit was not functioning as intended.Unit was investigated and it was found that the luer lock bag connector was damaged.Failure mode: luer lock collar failed and wasn't present to lock the buretrol line to bag connection.Review of product evaluation form shows device history record was not reviewed as customer did not provide a serial number.No associated capas found.Complaint history was reviewed for the previous two years and found 3 similar complaints, giving an incident rate (b)(4).Review of medical device hazard analysis identifies the hazard situation as "luer lock thread is stripped or broken" based on complaint of luer lock flew off.The risk level is considered bar.This determination is based on the information received by the customer who reported no patient injuries.This complaint will be included in trending data for further review and investigation if needed.
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Event Description
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While changing the collection bag on the codman eds iii drainage system, the luer lock flew off.No injury to patient.
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Search Alerts/Recalls
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