MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q EXPANSION KITS WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 2.5 IN (6.5 CM); CATHETERS

Model Number PM010-A

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

Patient Problem No Code Available (3191)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 06-may-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.(b)(4).

Event Description

Fill volume: 700 ml, flow rate: 1 to 3 ml/hr, procedure: pediatric vats performed on (b)(6) 2018, cathplace: top of the ribs.It was reported the patient experienced sustained axillary nerve apraxia after the use of the catheter.The doctors were not sure if the use of the pump and catheter contributed to the symptoms.The patient was not sure when the symptoms started during the infusion process.The device was removed on (b)(6) 2018.The neurology team was consulted and physical therapy (pt) was initiated prior to transfer of the patient.No additional information.

• Brand Name: ON-Q EXPANSION KITS WITH SILVERSOAKER ANTIMICROBIAL CATHETER, 2.5 IN (6.5 CM)
• Type of Device: CATHETERS
• 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 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7494637
• MDR Text Key: 107605269
• Report Number: 2026095-2018-00055
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 30680651135330
• UDI-Public: 30680651135330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2018

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: Other Health Care Professional
• Device Model Number: PM010-A
• Device Catalogue Number: 101353300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/08/2018
• 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
• Treatment: THE 0.1% ROPIVACAINE
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Weight: 35