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 Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the device was reported to be discarded therefore testing methods could not be performed.The lot number nor the device model was available therefore, the device history record review could not be performed.Results: as a device was not available for an evaluation no testing methods were performed, therefore results cannot be obtained.Conclusion: the root cause for the reported event of catheter break could not be identified as the device was not returned for analysis.However, it was reported the resistance was met along with the catheter "being stuck on something during removal in the office".Our sales representative paid a visit on (b)(6) 2015 to the physicians office to provide additional education to the customer and obtain additional information.The technical bulletin tips for preventing in-situ catheter breakage with the on-q* pain relief system provide the following recommendations: strategies that may help to dislodge the catheter: cover site with a warm compress, and wait 30-60 minutes and try again.Change patient position.Moving the area may dislodge the catheter, especially in orthopedic surgery.Flush the catheter with 3-5 ml of sterile normal saline.7 use aseptic technique to avoid potential contamination.Massage area.Using a rubber tipped hemostat, grip the catheter near the insertion site and pull gently.Never use a stainless steel, non-protected hemostat as this may cause more damage to the catheter, which may cause the catheter to break.If the catheter does not come out easily, do not continue to pull.8.What to do if the catheter breaks in situ: as mentioned above, various imaging techniques may be helpful in assessing the size and location of the retained catheter.Once identified, the surgeon must be notified in order to determine whether removing the catheter is prudent.While the catheter is sterile and inert, a retained catheter may cause negative clinical consequences.A clinical decision must be made based on calculated risk of leaving the catheter in the site vs.Performing a surgical procedure to remove the catheter from the patient.Information from this incident has been included in our product complaint trend reporting systems for monitoring, tracking and trending.Not returned to mfg.

Event Description

It was reported that a catheter broke inside a patient.The reporter called to find out if the catheter was radiopaque as the patient had been taken to the or to explore the area to see if they could find the segment.However, they were not successful.It was reported that the patient had a total abdominal hysterectomy on (b)(6) 2015, and was told to return to the physicians office on (b)(6) 2015 to have the catheter removed.It was reported that it was stuck on something during removal in the office, snapped and broke.The doctor at the time met resistance and when the catheter broke, the broken segment was discarded with the pump in the garbage.Additional information received (b)(6) 2015: it was reported that the patient did not feel comfortable pulling the catheter out at home and so waited to be seen by the doctor.On (b)(6) 2015, the patient saw dr.(b)(6) and the doctor pulled the catheter and felt it moving until the catheter suddenly snapped.It is estimated that approximately 2cm of the catheter was retained inside the patient.The doctor reported being able to feel the catheter fragment under the skin.The catheter was placed subfascial.The date of surgery was reported to be (b)(6) 2015.Additional information received on (b)(6) 2015.The retained portion of the catheter was removed from the patient.

• 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, b.c 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5170421
• MDR Text Key: 29344275
• Report Number: 2026095-2015-00274
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• 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
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• 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 Age: 42 YR
• Patient Weight: 49