MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN RELIEF SYSTEM T-BLOC ULTRASOUND NERVE BLOCK PREP TRAY; REGIONAL ANESTHESIA

Model Number TBT02

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

Patient Problem Unspecified Infection (1930)

Event Date 11/06/2017

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 05-dec-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 (b)(4).Device not returned.

Event Description

Fill volume: unknown; flow rate: unknown ; procedure: thumb surgery ; cathplace: unknown.It was reported that the patient was hospitalized and readmitted for intravenous (iv) antibiotics treatment for her infection after her thumb surgery.The physician attributed the cellulitis to the nerve block pump.The patient has been in and out of the hospital twice trying to recover from an infection that appears to be spreading in the patient's chest.The patient went to see the physician on tuesday after removing the pump on sunday evening, (b)(6) 2017.On monday the patient noticed a lump with noted redness under the skin at the site of insertion where the catheter was removed.The physician ordered antibiotics.By thursday, the infection was starting to spread and the redness was getting worse, so the patient went to the emergency room (er).The physician ordered a computed tomography (ct) and sonogram to rule out if any of the catheter was retained in the patient once the device was removed.The catheter was removed easily, the ct and sonogram were negative.The patient was admitted and given keflex intravenous (iv) and doxycycline (iv) , thursday and friday.Saturday, the patient was sent home on oral keflex.The patient came back to the hospital on sunday, (b)(6) 2017, because the oral medication was not effective and allowed the infection to continue to grow and spread.Currently, the patient was under the care of an infectious disease (id) physician and the patient was given vancomycin and ancef.On (b)(6) 2017 the patient's skin looked better that morning but that night it was starting to look bad again.Blood culture specimens were performed during both hospital visits and have been negative so far.Additional information received 04-dec-2017 stated the anesthesiologist confirmed that the patient's condition was resolving as she was discharged on (b)(6) 2017.The anesthesiologist also thinks that the condition was not a true infection but a reaction.No medical diagnosis was obtained.No additional information was provided.

Manufacturer Narrative

All information reasonably known as of (b)(6) 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 (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

Manufacturer Narrative

All information reasonably known as of (b)(6) 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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.

Event Description

Additional information received 04-dec-2017 stated the anesthesiologist confirmed that the patient's condition was resolving as she was discharged on (b)(6) 2017.The anesthesiologist also thinks that the condition was not a true infection but a reaction.No medical diagnosis was obtained.

• Brand Name: ON-Q PAIN RELIEF SYSTEM T-BLOC ULTRASOUND NERVE BLOCK PREP TRAY
• Type of Device: REGIONAL ANESTHESIA
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT, INC.; 6620 s. memorial place; suite 100; tucson AZ 85756
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7098604
• MDR Text Key: 94195022
• Report Number: 3006646024-2017-00028
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 30680651449154
• UDI-Public: 30680651449154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: TBT02
• Device Catalogue Number: 104078900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 73