MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q EXPANSION KIT: SILVERSOAKER; CATHETERS

Model Number PM050-A

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

Patient Problem Hemothorax (1896)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the actual device was not returned.A review of the device history record (dhr) was not performed.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.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: unknown, flow rate: unknown, procedure: truitt placement (left), cathplace: truitt placement (left).It was initially reported that a patient was admitted for trauma from falling down a cliff, and also had trauma to the clavicle, sternum, and rib.Two catheters were placed on the left side on (b)(6) 2016 at approximately t10 for multiple left side rib fractures.Surgery was necessary for the patient due to the location of one of the catheters into the left lung of the patient.The catheter was placed within the pleural cavity and had lower left lobe penetration.Currently, the patient has one catheter in since it was placed correctly.The most recent information received on 10-oct-2016 stated that the patient was discharged from the hospital without further details.

• Brand Name: ON-Q EXPANSION KIT: SILVERSOAKER
• 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, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6055731
• MDR Text Key: 58358588
• Report Number: 2026095-2016-00182
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2016

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: Health Professional
• Device Model Number: PM050-A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: 10680651135411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 10/25/2016
• 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: TUNNELER INTRODUCER SHEATH
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR