MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN CATHETER

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problems Discomfort (2330); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 21-nov-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

Event Description

Procedure: abdominoplasty.It was reported that a patient had a pump installed during an abdominoplasty operation.After the pump completed its infusion, the patient attempted to remove the two catheters.One was removed without issue.However, the second one was too tight for the patient to remove.At the patient's follow-up appointment, the physician broke off the second line.It was noted that none of the black lines or spots were noticed as the tube was removed.The physician did not see this as a problem.However, the patient's husband stated that the product literature suggests that it could be an issue.Additional information received on 31oct2017 received from the patient's husband stated that the catheter was caught in stitches when it was being removed.This resulted in significant discomfort for the patient upon removal because it was so difficult to remove.It was not fully removed and experienced ductile failure before any of the black lines or dots came out.It was noted that the physician threw the catheter away and it is not available for return.The patient's husband is concerned if they should be worried about the small section of catheter that still remains embedded in his wife.Additional information received on 07nov2017 from the patient's husband stated that his wife was experiencing significant lymphedema near the removal site.This issue is not present on the other side where the other catheter was easily removed.It was mentioned to the physician by the patient, but the physician suggested the patient try lymphatic massage.She had been doing that for about a week now with no success.No further information was provided.

Manufacturer Narrative

All information reasonably known as of 07-feb-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

• Brand Name: UNKNOWN CATHETER
• Type of Device: UNKNOWN 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 ; MX
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7054022
• MDR Text Key: 93258448
• Report Number: 2026095-2017-00197
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1