MAUDE Adverse Event Report: HALYARD - IRVINE CATHETER

Model Number UNKNOWN

Device Problems Split (2537); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: there were no methods performed.The device was not returned, and in addition the model and lot number were not available.Therefore, a review of the device history record (dhr) could not be performed.Results: as a device was not available for an evaluation, no methods were performed and results cannot be obtained.The instruction for use (ifu) specifies the following: "warning: 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., cautions: 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)." conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.Information from this incident has been included in our product complaint and mdr trend reporting systems.

Event Description

Patient 2, event 1 of 1: a scrub tech reported an incident of a catheter break, the catheter could not be removed from the patient.The patient had to be taken back to the operating room for removal.The event date is unknown, and the stock code and lot number are also not available.Patient consequence was not reported and patient age, weight, and gender were also not available.The physician would not provide further information and the sample is not available for return.

• Brand Name: CATHETER
• Type of Device: CATHETER
• 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 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5146322
• MDR Text Key: 28136848
• Report Number: 2026095-2015-00248
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention