MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN CATHETER

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Itching Sensation (1943); Pain (1994); Rash (2033); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

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.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).Device not available.

Event Description

Halyard received a single report that referenced four different incidents, which were associated with separate units, involving four different patients.This is the second of four reports.Refer to 2026095-2017-00024 for the first patient.Refer to 2026095-2017-00026 for the third patient.Refer to 2026095-2017-00027 for the fourth patient.Fill volume: 600 ml, flow rate: 4cc each side, procedure: pectus excavatum repair (pex), cathplace: posterior, away from incision site.A literature article was received from the journal of pediatrics entitle "surgical site infection related to use of elastomeric pumps in pectus excavatum repair.Lessons learned from root cause analysis." the article detailed patients who developed surgical site infections associated with the use of halyard health elastomeric homepumps and catheters.Of the patients who developed the surgical site infections, 2 grew staphylococcus epidermidis, 1 (b)(6), and 1 pseudomonas aeruginosa.¿silver-coated wound catheters were introduced before closure of the surgical wounds¿and the wound catheter was then fixed to the thoracic wall.¿ those with the surgical site infections were specified as have postoperative pain, fever, itching, wound breakdown, and skin rashes.The article noted that an increase over baseline was found during the initial review of surgical site infections for patients that had a catheter placed.

• 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, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6331326
• MDR Text Key: 67441087
• Report Number: 2026095-2017-00025
• Device Sequence Number: 1
• Product Code: MEB
• 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: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2017

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
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/15/2017
• 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
• Treatment: 0.1% ROPIVICAINE
• Patient Outcome(s): Other