MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number CB004

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

Patient Problems Nerve Damage (1979); No Code Available (3191)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

Occupation: patient/lay user.(b)(4): -smaller than the left -feels cold all the time -is painful because it's always cold -gives me slight/bothersome headaches -muscles feel very weak -it doesn't feel bright and alert -when i'm tired, it gets smaller -when i wake up if i'm tired,it gets very puffy (like a sty is on my eye-but there is no sty) -it feels like i am trying to "wake up" the eye.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 17-jul-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 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).Device not returned.

Event Description

Fill volume: 600 ml; flow rate: unknown; procedure: right shoulder/manipulation/scar tissue; cath place: unknown.It was initially reported by a patient on (b)(6) 2018 that they were experiencing eye issues described as "right eye small, cant open all the way, eye is cold and painful.Muscles aren't strong." these issues were associated with the use of an elastomeric pump after a surgery.The patient stated that ever since his surgery in (b)(6) 2018, he has had eye issues ever since the elastomeric pump.He notified his surgeon and anesthesia, but did not receive any calls back.On the same day of receiving medication via the elastomeric pump, his right eye "was smaller, (he) couldn't open it all the way, (his) eye has been cold, muscles aren't strong, (his) eye is weak and painful." additional information received from the patient (b)(6) 2018 stated he a scar tissue removal procedure done along with manipulation of his right shoulder.He was given anesthesia and was released with a 3-day numbing agent nerve catheter.On (b)(6) 2018, the patient stated that he noticed his right eye was significantly smaller than his left eye.The doctor stated that this was a side effect from the peripheral nerve catheter and that the size of the eye should return back to normal after the catheter was removed (3-day later).The patient stated that as of (b)(6) 2018, his eye never returned back to normal and he has experienced additional symptoms after the catheter was removed.The patient went to see his eye doctor on (b)(6) 2018 for a regular exam and expressed his complications he experienced with his eye.The eye doctor stated that his "right eye has ocular nerve damage from some of the agent getting into my nerve to my eye." it should return back to normal but may take a long time.The patient noted his right eye symptoms as the following: smaller than the left; feels cold all the time; is painful because it's always cold; gives me slight/bothersome headaches; muscles feel very weak; it doesn't feel bright and alert; when i'm tired, it gets smaller; when i wake up if i'm tired, it gets very puffy (like a sty is on my eye-but there is no sty); it feels like i am trying to "wake up" the eye.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR
• Type of Device: ELASTOMERIC - SAF
• 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: 7711283
• MDR Text Key: 114746873
• Report Number: 2026095-2018-00082
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CB004
• Device Catalogue Number: 101347202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2018
• 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
• Treatment: 0.2% ROPIVACAINE
• Patient Age: 45 YR