MAUDE Adverse Event Report: HALYARD ON-Q C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW; ELASTOMERIC PUMP

Model Number CB004

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

Patient Problem Bacterial Infection (1735)

Event Date 02/01/2015

Event Type  Injury  

Event Description

Fill volume: 500ml.Flow rate: 10ml/hr.Procedure: foot and ankle surgery.Cathplace: popliteal nerve block.Please reference; (b)(4).Report 2 of 2: a patient experienced a catheter site infection that required surgical intervention after use of a pump.The abscess was shallow and superficial.The patient"s wife reported that she had been rubbing ointment and lotion at the catheter site.Additional information was received on (b)(6)2015.The patient had an incision and drainage washout in the operating room.The patient was treated with levaquin at the hospital and then discharged home.At the time of this report the patient is reported as doing "fine".On (b)(4).Additional information was received on (b)(6)2015.The catheter was in for 5 days then removed; the infection was noticed 3 days later.The infection was near the popliteal area and not in the foot or ankle.The clinical specialist instructed the patient's wife not to apply lotions or creams to the site following the event.The device is not available for evaluation.Additional information was requested and it was reported that no further information will be available.Additional information was received on (b)(6) 2015.The saf dial was most likely set to 1ml/hr, but rate may have been adjusted.

Manufacturer Narrative

Method: the device is not available for return.As the lot number was unavailable, a 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.Conclusions: the device was not returned to halyard for an evaluation, therefore, we are unable to determine a cause for the reported event.Per the instructions for use (ifu) ((b)(4)), the onq pump is intended to provide continuous delivery of medication (such as local anesthetics) to or around surgical would sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and/or pain management.The ifu further states that it is the responsibility of the healthcare provider to ensure patient is educated on the proper use of the system.It was reported that ointment and lotion were applied at the catheter site.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 C-BLOC 400ML, 2-14ML/HR SELECT-A-FLOW
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4575429
• MDR Text Key: 21846205
• Report Number: 2026095-2015-00086
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/05/2015

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: CB004
• Device Catalogue Number: 101347200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2015
• 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: DRUG: ROPIVACAINE 0.2%; QUIKBLOC OVER-THE-NEEDLE CATHETER SET
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR