MAUDE Adverse Event Report: I-FLOW, LLC, A KIMBERLY-CLARK HEALTHCARE CO. ON-Q PAINBUSTER INT'L: SOAKER 5IN (12.5CM): 270 ML, 4 ML/HR (2+2); CATHETER CONDUCTION ANESTHETIC

Model Number PS12505

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/30/2013

Event Type  malfunction  

Event Description

Drug/diluent: not applicable.Fill volume: not applicable.Flow rate: not applicable.Procedure: sternectomy.Cathplace: sternum bilaterally.Date of surgery: (b)(6) 2013.The pediatric hospital of (b)(6) complained of an incident with the peel-off tunneler sheet which was broken during the procedure of inserting the catheter and 5 cm piece of tunneler sheet has remained inside the child's incision.They were performing a sternotomy and were inserting the catheters bilaterally of the sternotomy incision.The missing piece is still inside the patient on the left side of the sternotomy wound.Patient is reported to be in good condition and discharged home.Patient had previous medical issue, unknown heart condition.The catheter placed was an i-flow catheter.Surgeon is not yet planning removal of the piece as it is small.The nurse was not able to find tunneler or sheath lot information in chart.The patient had a post op clinic control and check up was fine and is recovering well without complications.

Manufacturer Narrative

Method: actual device not evaluated.No testing methods were performed.As no lot number or model information was obtained a review of the device history record (dhr) could not be conducted.Results: no results available since no evaluation performed.The device was disposed of.Conclusion: device was not returned for an evaluation and investigation.Inconclusive-investigation is still in progress.At this time we are attempting to gather additional information, the investigation is ongoing.Information from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend information, or other analysis as appropriate.Device was disposed of.

Manufacturer Narrative

The sample was discarded and unavailable for returned.A review of the device history record (dhr) was conducted and the directions for use (dfu) were evaluated with the reported user conditions.Based on the dhr review for the reported lot number there were no non conformance reports, reworks or special conditions during product manufacturing associated to the reported condition.The production lot met all manufacturing and quality specifications.The directions for use (14-60-602) provide the following instructions: warnings do not reinsert a partially or completely withdrawn needle as this can damage the sheath and break off in patient upon sheath removal.Failure to remove introducer sheath from the body before peeling may result in a segment of sheath breaking and being retained in the patient.This may lead to an injury.Placing the catheter prime catheter with 5 ml syringe to ensure patency (figure 2 on page 6).Gently hold t-handle and remove protective guard.Introducer needle: insert (bevel up) through the skin approximately 3-5 cm from surgical site (figure 3 on page 6).Tunneler: follow standard surgical practice to create an entrance incision.Advance introducer to desired location for catheter placement.Introducers with luer lock may be connected to a syringe to aspirate or inject a bolus of fluid or medication.While holding t-handle (1), withdraw trocar (2) from sheath (figure 4 on page 6).Caution: do not reinsert a partially or completely withdrawn needle as this can damage the sheath and break off in patient upon sheath removal.Advance catheter through sheath until entire infusion segment is within desired location (figure 5 on page 6).Caution: place catheter such that obstruction will not occur and catheter removal will not be impeded.Prior to final suturing, make sure catheter moves freely to ensure it¿s not caught in sutures.Assure that catheter is not in a vein or artery.Caution: while holding catheter tip (1), withdraw sheath completely from puncture site prior to splitting to avoid sheath breaking off in patient (2).Split sheath and peel away from catheter (3) (figure 6 on page 6).Prime catheter again with 5 ml syringe to ensure patency (figure 7 on page 6).Discard introducer per standard hospital protocol.Conclusion: at this time a cause cannot be determined.The sample was not returned for an analysis.The device history record review determined that the production lot met all manufacturing and quality specifications.Based on this investigation the complaint disposition is unable to evaluate.This incident has been included in our complaint handling database, which we actively monitor and trend.

• Brand Name: ON-Q PAINBUSTER INT'L: SOAKER 5IN (12.5CM): 270 ML, 4 ML/HR (2+2)
• Type of Device: CATHETER CONDUCTION ANESTHETIC
• Manufacturer (Section D): I-FLOW, LLC, A KIMBERLY-CLARK HEALTHCARE CO.; 20202 windrow drive; lake forest CA 92630
• Manufacturer Contact: maria wagner ; 20202 windrow drive; lake forest, CA 92630 ; 9495973957
• MDR Report Key: 3590278
• MDR Text Key: 21104865
• Report Number: 2026095-2014-00007
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: PS12505
• Device Catalogue Number: 101360500
• Device Lot Number: 0201040134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2013
• 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 Age: 4 YR