MAUDE Adverse Event Report: HALYARD-IRVINE ON-Q PUMP SILVERSOAKER 1IN(6.5CM):100ML, 2ML/HR; CATHETER

Model Number PM032-A

Device Problem Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Procedure: total knee replacement cath place:knee it was reported that a catheter broke while inside a patient.It was reported that a nurse attempted to remove a catheter and experienced difficulty and upon pulling the catheter it "stretched and pulled apart".A piece of the broken catheter was retained inside the patient.Patient demographics and date of event were asked but not available.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 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.One the device is received, testing will be performed and results will be provided upon completion.Conclusions: 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 and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.Device return anticipated.

Manufacturer Narrative

Method: the device was reported as not available for return and analysis.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.The instructions for use (ifu) specifies the following: warnings "do not suture through catheter to avoid catheter breakage during removal.Catheter removal remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter.Remove dressing and loosen the adhesive strips at catheter site (figure 10 on page 2).Grasp catheter close to skin and gently pull to remove.The catheter should be easy to remove and not painful.Do not tug or quickly pull on catheter during removal.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." 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.Multiple attempts were made to obtain additional information without success.It was reported that the nurse experienced difficulty upon pulling the catheter and it appeared stretched and pulled apart; therefore, the use error may have contributed to the reported event.However, without the device, the complaint in not able to be evaluated and a root cause cannot be determined.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 PUMP SILVERSOAKER 1IN(6.5CM):100ML, 2ML/HR
• 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: 4621786
• MDR Text Key: 5590429
• Report Number: 2026095-2015-00108
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: PM032-A
• Device Catalogue Number: 101372200
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• 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): Other