MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q CATHETER

Model Number TBT02100T

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

Patient Problem Unspecified Infection (1930)

Event Date 08/27/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: as a device analysis cannot determine the root cause of the post-operative infection, no device testing methods are available.Conclusions: as the device analysis cannot determine the root cause of the post-operative infection, we are unable to determine the cause of the reported event.Post-operative infection can be due to multiple variables.Patient factors, healthcare provider factors, technique factors, medical device/product factors, equipment factors, environmental factors are a few variables to consider.The instructions for use (ifu), specifies, "catheter removal: remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter." information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

Event Description

Procedure: total knee replacement surgery ((b)(6) 2015).Cathplace: asku.Please reference: 2026095-2015-00238/15-00863.Device 2 of 2: it was reported that a patient experienced an infection with the use of a catheter.A home health nurse advised the patient to return to the doctor's office after the patient experienced a fever for 6 days with redness at the surgical site.The patient was seen and due to the appearance of cellulites, a prescription for keflex 500mg was provided.Additional information was received on 08-28-2015.A nurse practitioner (np) reported that the patient was seen in the evening clinic and there was no leakage or anything to culture.The np saw what appeared to be cellulitis and the patient was prescribed an antibiotic.Additional information was received on 09-10-2015.A medical assistant reported that the patient was seen on (b)(6) 2015 for an i & d of the right thigh abscess.The abscess was improving and appeared smaller in size than before and was draining; however, the patient had the i&d and was prescribed doxycycline.The pump had infused for approximately 5-7 days.The patient was seen in the doctor's office on (b)(6) 2015 and the device was already removed.The device is unavailable for return.

• Brand Name: ON-Q CATHETER
• Type of Device: CATHETER
• 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: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5101057
• MDR Text Key: 26674240
• Report Number: 2026095-2015-00239
• 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: company representative,health
• Reporter Occupation: Medical Assistant
• Type of Report: Initial
• Report Date: 08/27/2015

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: TBT02100T
• Device Catalogue Number: 104078400
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2015
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BYSTOLIC
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 85