MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAINBUSTER SOAKER 5 IN(12.5CM): 270ML, DUAL 2+2ML/HR; ELASTOMERIC PUMP

Model Number PM025

Device Problems Stretched (1601); Material Distortion (2977); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/26/2015

Event Type  Injury  

Event Description

Procedure: breast augmentation.Cathplace: in the breast under the muscle.It was reported that a catheter broke upon removal.The catheter is available for evaluation.Additional information was received on (b)(6) 2015.The patient had surgery on (b)(6) 2015.The catheter was removed on (b)(6) 2015.The patient did not experience discomfort during removal; however, the patient felt the catheter tugging.No devices were used to remove the catheter.Resistance was met when removing the catheter.The catheter stretched and appeared grayish/white before breaking.The catheter broke inside of the patient.About 1.5 inches of catheter was retained inside of the patient.The retained segment was not removed and no additional medical intervention was given.The patient was reported as doing well.

Manufacturer Narrative

(b)(4).Method: the device was received for analysis.A visual inspection and a review of the device history record (dhr) are currently in process.Results: there are no device testing results available as the investigation and evaluation are currently in progress.Conclusions: once the analysis and investigation are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Manufacturer Narrative

Method: the dual catheters were received for testing and analysis.In addition to the visual inspection, a photographic images, tensile strength testing, and microscopic inspection were performed.A review of the device history record (dhr) and instructions for use (ifu) was performed.Results: catheter #1 was returned not fully intact, it was missing the black catheter tip.Evidence of attenuation was observed throughout the catheter and infusion segment where the breakage occurred.The diameter of the attenuated broken segment was measured to be 0.019¿.The non-attenuated segment was measured to be 0.0044¿.The soaker catheter was examined under a microscope magnified at 2x, no signs of brittleness were observed.Tensile strength testing was performed on the soaker catheter #1.The passing rate for the test is >2.8(lbf) at the infusion segment and >4.00 (lbf) for the mid-body segment.The result for the catheter mid-body segment was 9.36(lbf).Tensile strength testing was not performed on the infusion segment portion due to length.The catheter met specifications during the tensile strength testing and no additional testing was performed.Catheter #2 was returned fully intact.No damages were observed at the catheter.The catheter's diameter was measured to be 0.0044'.The soaker catheter was examined under a microscope magnified at 2x, no signs of brittleness were observed.Tensile strength was performed on the soaker catheter #2.The passing rate for the test is >2.8(lbf) at the infusion segment and >4.00 (lbf) for the mid-body segment.The result for the catheter's mid-body segment was 11.94(lbf) and infusion segment was 4.98(lbf).The catheter met specifications during the tensile strength testing and no additional testing was performed.The dhr of the reported lot was reviewed.According with the results, the production lot met all manufacturing and quality specifications.The production lot met all manufacturing and quality specifications at release.The ifu advises ¿if resistance is encountered during removal, or if the catheter stretches, stop, continued pulling could break the catheter.It is advisable to cover the site with warm compress and, wait 30-60 minutes and try again.The patient¿s body movements may relieve the catheter to allow easier removal.If the catheter is still difficult to remove, an x-ray is recommended.¿ conclusion: the used catheters were returned for testing, and the investigation summary concluded that catheter #1 was returned not fully intact and missing the black catheter tip.Evidence revealed that attenuation was observed where the breakage occurred.Tensile strength testing was performed on the mid-body segment and the catheter met specifications.Soaker catheter #2 observed no damages and met specifications during the tensile strength testing.It was reported that the user felt resistance (4/5) while removing the catheter, the catheter had stretched and appeared grayish/white before breaking.Based on the investigation results and the reported information, the catheter broke due to excessive force.Therefore, the complaint disposition is confirmed.Information from this incident has been included in our product complaint and mdr trend reporting system.

• Brand Name: ON-Q PAINBUSTER SOAKER 5 IN(12.5CM): 270ML, DUAL 2+2ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4726731
• MDR Text Key: 16855941
• Report Number: 2026095-2015-00136
• Device Sequence Number: 1
• Product Code: MEB
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 05/31/2017
• Device Model Number: PM025
• Device Catalogue Number: 101364000
• Device Lot Number: 0202037092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TAGADERM; BUPIVACAINE 0.5%
• Patient Outcome(s): Other
• Patient Age: 21 YR