MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN BUSTER: SOAKER 5 IN, 270ML X DUAL 2X2ML/HR; ELASTOMERIC PUMP

Model Number PM025

Device Problems Stretched (1601); Cut In Material (2454)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: a portion of the device has been received for evaluation and investigation.A visual inspection has been performed, and continuation of testing is currently undergoing.A review of the device history record (dhr) was conducted.Results: test method results will be provided once the evaluation and investigation have been completed.According with the dhr results, the production lot met all manufacturing and quality specifications.

Event Description

It was reported by our sales representative that a catheter broke off in a patient upon removal.The patient underwent a breast augmentation surgery on (b)(6), 2015.The catheter piece was retained in the patient.Additional information received oct.02, 2015: the catheter was removed by the patients friend on (b)(6), 2015 in the am.Upon removal the infusion area (black markings) were not present and the catheter appeared to be stretched and/ or cut and grayish white a little at the end.The retained segment has not been removed, and it is believed that there us a 1/2 inch at most retained inside the patient.It was also reported that there was no patient injury or medical intervention required, and a portion of the catheter is available for return.

Manufacturer Narrative

(b)(4).Method: actual device was received for evaluation and investigation.A visual inspection and tensile strength test were conducted.A review of the device history record (dhr) was performed.Results: the catheter was returned not fully intact, missing the infusion segment.There is evidence of stretching approximately 1.77¿ distal to the 2nd markings and continues throughout the catheter.The damaged part was measured to be 0.016¿ and the non-damaged part was measured to be 0.041¿.The catheter was examined under a microscope magnified at 1.6x, no signs of brittleness were observed.Tensile strength was performed on the catheter.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 10.29(lbf).Testing was not performed on the infusion segment because it was not received.The catheter met specifications during the tensile test and no additional testing was performed.Conclusion: the investigation summary concludes that the catheter was received not fully intact, missing the infusion segment.Evidence revealed that stretching was observed where the breakage occurred.Tensile strength was performed on the midbody segment and met specifications.Excessive force failure mode was chosen because during visual observation of the catheter, stretching and breakage was observed.Tensile strength on the mid-body met specifications.Using excessive force >4.00(lbf) on the catheter at the midbody segment and >2.8(lbf) at the infusion segment will cause it to break.The instructions for use (ifu) specifies, "if resistance is encountered or catheter stretches, stop.Continued pulling could break the catheter.¿ it¿s advisable to cover the site with warm compresses, and wait 30 to 60 minutes, and try again.The patient¿s body movements may relieve the catheter to allow easier removal.¿ for additional information refer to the technical bulletin: tips for preventing in-situ catheter breakage with the on-q* system.¿ do not cut or forcefully remove catheter.¿ after removal, check distal end of catheter for black marking to ensure entire catheter was removed (figure 12 on page 2)." an instructions for use (ifu) and a technical bulletin, preventing catheter breakage, were sent to the customer.Based on the device history record review for the reported lot number (0202172813) 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.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.

• Brand Name: ON-Q PAIN BUSTER: SOAKER 5 IN, 270ML X DUAL 2X2ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, bc
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618
• MDR Report Key: 5167103
• MDR Text Key: 29065835
• Report Number: 2026095-2015-00273
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 11/30/2017
• Device Model Number: PM025
• Device Catalogue Number: 101364000
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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: 25 YR
• Patient Weight: 63