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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.L.R. KM7 TUBING, INSUF W/ .1 MICR FLT, ECONOMY; TUBING/TUBING W/FILTER INSUFFLAT LAP

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DEROYAL INTERCONTINENTAL, S.L.R. KM7 TUBING, INSUF W/ .1 MICR FLT, ECONOMY; TUBING/TUBING W/FILTER INSUFFLAT LAP Back to Search Results
Catalog Number 28-0207
Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964)
Patient Problem No Patient Involvement (2645)
Event Date 12/03/2013
Event Type  malfunction  
Event Description
Co2 could not flow thru the filter.
 
Manufacturer Narrative
When the report was received the qc complaint specialist contacted the qc to request a copy of the work order for a review on (b)(6)2013.The work order was supplied for review on (b)(6) 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, (b)(4) testing was also performed and documented within the work order.A total of 125 tests were conducted and all passed.The actual sample from the customer and representative samples from the same lot number was provided to deroyal engineering for evaluation.Refer to the corp.Pcl.016 summary report attachment.Correction: a replacement has been provided on order # 3270600.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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Brand Name
TUBING, INSUF W/ .1 MICR FLT, ECONOMY
Type of Device
TUBING/TUBING W/FILTER INSUFFLAT LAP
Manufacturer (Section D)
DEROYAL INTERCONTINENTAL, S.L.R. KM7
autopista joaquin balaguer
pisano free zone, bldg 49
santiago
DR 
Manufacturer Contact
200 debusk lane
powell, TN 37849
8653622333
MDR Report Key4688264
MDR Text Key5716623
Report Number3004605321-2015-00003
Device Sequence Number1
Product Code NKC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 04/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/20/2018
Device Catalogue Number28-0207
Device Lot Number32847601
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/09/2013
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/03/2013
Event Location Hospital
Date Manufacturer Received12/03/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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