MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q EXPANSION KIT SILVERSOAKER 2.5IN(6.5CM); CATHETER, CONDUCTION, ANESTHETIC

Model Number PM010-A

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

Patient Problem Unspecified Infection (1930)

Event Date 03/11/2015

Event Type  Injury  

Event Description

Please reference: 2026095-2015-00140/(b)(4) and 2026095-2015-00141/(b)(4).Procedure: c-section.Cathplace: right side of abdomen.Device 3 of 3: it was reported that a patient had a surgical site infection post-operatively.A pump and 2 catheters were used on the patient for post-operative pain management.The patient was discharged on (b)(6) 2015 with the pump.On (b)(6) 2015, the patient was readmitted to the hospital with fever and drainage from the surgical site.The patient was treated with iv vancomycin and ceftazidime at the hospital.The patient was discharged on (b)(6) 2015 with oral keflex.The device is not available for return.Additional information was requested, however is not available at this time.

Manufacturer Narrative

(b)(4).Method: actual device not evaluated.Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the review of the device history record (dhr) cannot be conducted.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.Limited information was provided by the reporter.The instructions for use (ifu) specifies, "use aseptic technique" "filling the on-q* pump: (figure 3) note: follow hospital protocols and applicable regulations for filling pump." in addition the ifu provides warnings and cautions regarding minimizing the risk for a possible infection.Per the ifu, warnings "remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter." cautions: "reuse of the device could result in the following risk: ¿ increased risk of infection." conclusions: the device was not returned to (b)(4) for evaluation, therefore we are unable to determine the cause for the reported event.Limited information was provided by the reporter.Multiple attempts were made to obtain additional information without success.The ifu provides warnings and cautions regarding minimizing the risk for a possible infection.Per the ifu, warnings "remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter." cautions: "reuse of the device could result in the following risk: ¿ increased risk of infection." 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.

• Brand Name: ON-Q EXPANSION KIT SILVERSOAKER 2.5IN(6.5CM)
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• 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. 2211 6; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4746160
• MDR Text Key: 5885661
• Report Number: 2026095-2015-00144
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2015

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: Lay User/Patient
• Device Model Number: PM010-A
• Device Catalogue Number: 101353300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 05/04/2015
• 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
• Patient Sequence Number: 1
• Treatment: MARCAINE 0.5%; ON-Q PUMP 400ML, 4ML (2+2 DUAL SITE)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 61