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 Dysphagia/ Odynophagia (1815); Erythema (1840); Swelling (2091); Reaction (2414); Alteration In Body Temperature (2682); No Code Available (3191)

Event Date 05/31/2017

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.All information reasonably known as of 11-jul-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

Fill volume: 125 ml, flow rate: 8 ml/hr, procedure: rotator cuff repair, cathplace: unknown.It was reported that a patient went to the emergency room (er) because of allergic reactions to local anesthetic.It was noted that on (b)(6) 2017, the patient's throat felt strange and he could not swallow after taking antibiotics and pain pills while connected to the elastomeric pump.The patient was administered benadryl iv and oxygen while in the ambulance on the way to the er.Redness the patient experienced dissipated and the pump was removed while in the er.The patient was not admitted to the hospital.The discharge notes stated that the patient experienced an adverse reaction to the local regional block and was discharged home on (b)(6) 2017.Additional information has been requested but not yet received.

Manufacturer Narrative

Corrected data: date of event.(b)(4).All information reasonably known as of (b)(4) 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).

Event Description

Additional information received on (b)(6) 2017 in the form of the risk management worksheet for the patient.The notes state: "(b)(6) or nurse noticed red inflamed area on patient's neck around opposite as she was talking to him in the preop area.Two red areas were also notices on chest the size and shape of ekg leads.Pt denied any allergies to neds and adhesive.25 mg of iv benadryl & 8mg of decadron was given to pt.Doctor notified about patient's redness on nec ad chest.Post surgery after drapes were removed to put dressing on.Pt's redness and swelling was gone.Patient denied itching or sob.(b)(6) 2017 upon postop call, pt states he took antibiotic at 8 pm.Noticed throat felt strange at 10pm.Tried to swallow water, could not and then fell on floor.911 was called.Was in er until 3am.Onq pain pump removed.(b)(6) 2017 er records received.Pt was given 25 mg benadryl after iv access was established.O2 started.In ambulance on way to er.Patient was received into et and stated he became hot and felt like he couldn't talk or take a deep breath.Throat felt scratchy, symptoms started 2.5hrs after percocet and ceftin.Patient denied hx of falls.Patient was alert and oriented to ppt.Pt said that he had experienced some localized redness and possibly some sob after he had his catheter placed prior to the surgery.He had the surgery and had no other issues until the incident prior to going to the er.He clamped the catheter prior to going to er.He said he does feel better.Symptoms are localized but most sere to right neck, throat.Ekg and chest xray were ordered.Er diagnosis is adverse reaction to regional block anesthetic.".

• 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, bc
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6706027
• MDR Text Key: 79786039
• Report Number: 2026095-2017-00128
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2017
• 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
• Treatment: THE 0.2% ROPIVACAINE 500 ML
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR