MAUDE Adverse Event Report: HALYARD - IRVINE SILVERSOAKER 5 INCH DUAL CATHETERS

Catalog Number ASKU

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/20/2015

Event Type  Injury  

Event Description

Procedure: c-section ((b)(6) 2015) cathplace: abdomen-above rectus muscle, fascia area.It was reported by the patient's family member that a catheter break occurred during removal.It was initially reported that the patient's family member was able to remove the first of the dual catheters easily along with the black tip intact on the end of the catheter.When the second catheter did not easily come out, the family member was advised to place warm compresses and to change the patient's body positions.After 30 minutes, the catheter removal was attempted again and resistance was still met; however, it was reported that the catheter was moving somewhat.Again, the family member was instructed to alternate warm compresses with body position changes.The family member was also instructed to not tug on the catheter or to stretch it when removing.Upon removal of the catheter resistance was met and it was rated to be 4 out of 5.The catheter appeared stretched right before it broke.Upon removal, the family member noted that medication was dripping out of the end of the catheter and that the catheter looked several inches shorter than the first catheter.In addition, the black tip was not seen on the end of the catheter.An estimated 2 inches of catheter was retained inside the patient.The patient experienced a little discomfort during the removal of the catheter.The patient was instructed to contact the surgeon.Additional information was received on 07/01/2015.The catheter break occurred between the 1st and 2nd black marker and an estimated 7 inches of catheter was left inside the patient.The patient was seen by the physician on (b)(6) 2015 and the patient did not have any discomfort related to the broken catheter.The risks of leaving the catheter inside were explained to the patient; as the patient was planning to have another child, it was decided, barring any complications, to wait and remove the catheter in approximately 2 years when the patient underwent another c-section.A technical bulletin on preventing catheter breaks was provided to the physician.The catheter is available for return and additional information was requested regarding the device, however is not available at this time.

Manufacturer Narrative

(b)(4).Actual device not evaluated.The device was reported to be returning for an evaluation and at this time is pending return.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted at this time.At this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.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

Methods: actual device was received for an evaluation and investigation.A visual inspection, tensile strength and microscopic inspection were performed.Results: a visual inspection found that a silversoaker catheter was returned not fully intact, missing the black catheter tip.Evidence of stretching at the 3rd markings was observed and further observed throughout the entire catheter.The infusion segment and black catheter tip was found to be broken.The silversoaker catheter was examined under a microscope and found no signs of brittleness.A tensile strength test was performed on the catheter and the result for the catheter mid-body segment met specifications.Conclusions: the investigation summary concluded that the silversoaker catheter was received not fully intact, missing the black catheter tip and infusion segment.Evidence revealed that stretching was observed where the breakage occurred.A tensile strength test was performed on the mid-body segment and met specifications.It was determined that incorrect use may have contributed to the reported incident, due to the evidence that stretching and breakage was observed on the catheter; therefore, excessive force may have contributed to the incident.Additionally, it was reported that a 4/5 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) (14-60-602-0-04) and a technical bulletin, preventing catheter breakage, were sent to the customer.In a continuous effort to improve, a broken catheter complaints awareness training has been implemented.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: SILVERSOAKER 5 INCH DUAL CATHETERS
• 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, b.c.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4909471
• MDR Text Key: 6028987
• Report Number: 2026095-2015-00195
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2015

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?: Yes
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2015
• Initial Date FDA Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: ON-Q PUMP 400ML, 4ML/HR DUAL
• Patient Outcome(s): Other