DEROYAL INTERCONTINENTAL, S.L.R. KM7 TUBING, INSUF W/ .1 MICR FLT, ECONOMY; TUBING/TUBING W/FILTER INSUFFLAT LAP
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Catalog Number 28-0207 |
Device Problems
Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/06/2014 |
Event Type
malfunction
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Event Description
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Flow not going thru to patient.Not showing blockage not showing a lead, just won't flow.
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Manufacturer Narrative
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Investigation findings: a previous review of the work order was performed on 12/09/2013.The review of the work order identified that raw material products subjected to an in process inspection and was documented on the in-process inspection report, acd.Frm.005.Testing was also performed and documented within the work order.A total of (b)(4) tests were conducted and all passed.Due to a previous report testing was conducted on the finished good and lot number provided.The actual samples for this report was received on 03/04/2014 and forwarded to deroyal engineering for additional evaluations.Correction: a replacement has been provided on order # (b)(4).Root cause analysis: the customer's report of the product having a filter issue is unable to be confirmed.The complaint item and the additional products reviewed of the same lot number passed all testing and the acceptance criteria which the fda defines as a safe and effective flow rate.The additional testing of the representative samples and results gathered, confirm the filters and tubing allow sufficient flow of the co2 gas to establish and maintain pneumoperitoneum.Corrective action and/or systemic correction action taken: due to the root cause determination a corrective action has not been taken.Preventive action: a preventive action has not been taken.No further information available at this time.The investigation is complete.
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Search Alerts/Recalls
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