MAUDE Adverse Event Report: AVANOS MEDICAL, INC. UNKNOWN CATHETERS

Model Number UNKNOWN

Device Problem Cross Reactivity (1137)

Patient Problems Purulent Discharge (1812); Fever (1858); Nausea (1970); Pain (1994)

Event Date 08/31/2018

Event Type  malfunction  

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.All information reasonably known as of 27-sep-2018 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 avanos medical, inc.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 avanos medical, inc.Avanos medical, inc.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

Fill volume: unknown.Flow rate: unknown.Procedure: laparoscopic abdominal surgery.Cathplace: lower abdomen.It was reported that there was puss and a "gooey liquid" at the insertion site when the catheter was removed.Furthermore, it was reported it hurt to stand and the patient was nauseated and had a low grade fever.The first catheter for the on-q came out easy with no problems.The second catheter was leaking the whole time.The patient did not receive very good pain control when the second catheter was pulled it out, there was puss and a "gooey liquid" that had to be wiped away.The patient had a knot the size of pea in her abdomen where the needle was and it was not noted when the first catheter was removed.The patient stated it hurt to stand and the patient got nauseated and had a low grade fever.The patient's surgeon's nurse, who was in a different state from the patient, suggested that the patient get a urine test because the patient stated she was having bladder pain as well.The patient felt like "it's pulling" when she tried to use the bathroom.The patient was also going to follow-up with her surgeon regarding the pea size knot and the "gooey substance" upon removal.The patient was to follow-up with a physician in two weeks and the nurse explained that she could not give medical advice as to prognosis.Additionally, the patient sought further treatment to find out why she had a knot where the catheter was removed.She had a low grade fever and bladder pain.The patient says that it felt painful to stand and felt like her bladder was "twisting".She also said that when she removed the catheter a lot of "gooey liquid" came out with it.Patient had a scab around the area on the skin but it was not draining or red.The patient reported she would follow-up at an urgent care as soon as her mom could take her.

• Brand Name: UNKNOWN CATHETERS
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 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 30004 ; 4704485444
• MDR Report Key: 7917786
• MDR Text Key: 122638351
• Report Number: 2026095-2018-00097
• 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,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/04/2018

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: 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Weight: 61