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

Catalog Number 28-0207

Device Problems Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

Flow not going thru to patient.Not showing blockage not showing a lead, just won't flow.

Manufacturer Narrative

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.

• 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 Key: 4688267
• MDR Text Key: 5691532
• Report Number: 3004605321-2015-00004
• Device Sequence Number: 1
• Product Code: NKC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• 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 Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2018
• Device Catalogue Number: 28-0207
• Device Lot Number: 32847601
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/04/2014
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2014
• Event Location: Hospital
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other