MAUDE Adverse Event Report: HALYARD HEALTH - IRVINE ELASTOMERIC PUMP; ON-Q EXPANSION KIT: SILVER SOAKER 5IN

Model Number PM020-A

Device Problem Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received for analysis.A visual inspection was performed on the device at this time testing is ongoing.A review of the device history record (dhr) was reviewed for the model and lot number provided.Results: at this time the evaluation is still in progress.Results will be provided once completed.According with the results of the dhr review, the production lot met all manufacturing and quality specifications.Conclusion: once the investigation and device analysis are completed a follow-up report will be submitted.Information from this incident has been included in our product complaint trend reporting systems for monitoring, tracking and trending.

Event Description

It was reported that upon removal a catheter broke, there was some resistance met while removing the catheter.The patient experienced some discomfort during removal.The nurse repositioned the patient and tighten the skin area and removed the catheter.The catheter appeared broken with the black tip missing.It was estimated that approximately 1 inch was retained.The catheter did not appear stretched or clean cut.The surgeon did not encounter any difficulty inserting the catheter.A ct scan will be performed to determine the location of the catheter fragment.The patient's current condition is stable.It was reported as unknown if the catheter may have been sutured through.The patient had undergone a posterior lumbar fusion surgery on (b)(6) 2015.

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: a visual inspection found that two catheters were returned with the pump.Only one catheter will be tested because the other catheter had no issues when removing from the patient.The catheter was returned not fully intact, missing the black catheter tip.Multiple kinks observed at the infusion segment where the breakage is.The diameter of the kinked part was measured to be 0.025¿.The non-kinked part was measured to be 0.043¿.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 is 9.04(lbf).The result for the infusion segment is 4.55(lbf).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 black tip.Evidence revealed that stretching was observed where the breakage occurred.Tensile strength was performed on the mid-body segment and met specifications.The dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.It was reported that resistance was met when removing the catheter.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) ((b)(4)) and a technical bulletin, preventing catheter breakage, were sent to the customer.Should additional information pertinent to this case be received, 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.

• Brand Name: ELASTOMERIC PUMP
• Type of Device: ON-Q EXPANSION KIT: SILVER SOAKER 5IN
• Manufacturer (Section D): HALYARD HEALTH - 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, b.c
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232400
• MDR Report Key: 5206734
• MDR Text Key: 30777150
• Report Number: 2026095-2015-00311
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051401
• 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: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: PM020-A
• Device Catalogue Number: 101353501
• Device Lot Number: 0202204633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2015
• 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: 42 YR
• Patient Weight: 122