MAUDE Adverse Event Report: HALYARD-IRVINE; CATHETER

Device Problem Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/24/2015

Event Type  Injury  

Event Description

Procedure: ankle fusion.Cath place: behind knee.A patient reported an incident of catheter break.It was reported as, "tubing broke at silver part".The patient spoke with pa and the patient denied pain.It was further reported that "wire broke at purple part and silver part left in".Fluid was leaking from break "in wire".Additional information was received on (b)(4) 2015.It was reported that the catheter fragment was retained inside the patient after the patient was seen in the er.The patient was provided a prescription for "use after block wore off".The patient reported experiencing pain.It was reported that the break "in wire" happened when patient got tubing wrapped around her leg when getting up.The patient's friend reported that "he was removing catheter".The catheter fragment was reported to be available for return and analysis.Patient age and weight were not reported.Additional information was requested, however is not available at this time.

Manufacturer Narrative

(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.As a lot number for the device involved in the reported incident was not received, a review of the device history record (dhr) could not be conducted.Results: at this time, halyard is pending the receipt of the device and as the investigation is still in progress, results are not available.Once the device is received, results will be provided upon completion of the evaluation.Conclusions: once the investigation and evaluation 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.Device expected to be returned.

Manufacturer Narrative

(b)(4).Method: the device was not received for return and analysis.Results: as the device was not available for analysis, no device testing methods were performed.For this reason results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.Limited information was provided by the reporter.Attempts were made to obtain additional information without success.It was reported that "a break 'in wire' happened when patient got tubing wrapped around her leg when getting up"; thus, this may have contributed to the reported incident.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: NI
• Type of Device: CATHETER
• 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: 4614958
• MDR Text Key: 5760784
• Report Number: 2026095-2015-00109
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 03/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• 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