MAUDE Adverse Event Report: HALYARD - IRVINE, CALIFORNIA ON-Q CATHETER, SILVERSOAKER 7.5IN(19CM); CATHETER, CONDUCTION, ANESTHETIC

Model Number PM050-A

Device Problem Leak/Splash (1354)

Patient Problem Unspecified Infection (1930)

Event Date 11/06/2014

Event Type  Injury  

Event Description

Procedure: rib fracture repair.Cathplace: lateral and horizontal with the spine and the posterior side of patient.Infusion start: (b)(6) 2014.Infusion end: (b)(6) 2014- pump reported as not empty at the time of disconnection.It was reported that a patient experienced a catheter site infection, manifested by pain at site, fever, and brown drainage, following use of silversoaker catheters placed for a rib fracture repair.The catheters were placed on (b)(6) 2014 in the intensive care unit (icu).Throughout the infusion, the patient had leakage at the exit site and extra dressings were placed.The patient was discharged from the hospital on (b)(6) 2014.One of the catheters was removed on (b)(6) 2014 and the patient reported that he had severe pain at the catheter entry site and fever.On (b)(6) 2014, the other catheter was removed and the patient went to the emergency room.The patient was treated for the infection with doxycycline and tylenol for fever.It was reported that the patient is getting better but still has pain, fever and yellow drainage.The patient discarded the devices.It was reported that the pump was attached in the icu after breaking down the sterile field.

Manufacturer Narrative

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.A review of the instructions for use (ifu) and use review were performed.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.Per the ifu (14-60-602-0-04), the antimicrobial effects of silversoaker catheters has been shown to be active for up to 10 days.The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised.The catheters should be maintained per standard hospital protocol.The catheter should be removed as soon as infusion is complete to reduce the risk of infection and difficulty removing catheter.In case of infection, treatment with appropriate local and/or systemic antimicrobial agents may be required.The use review indicated that the patient did not receive prophylactic antibiotics.The pump was attached in the icu at the bedside after breaking down the sterile field.It was also reported that the patient and his daughter were "pushing the drainage out" of the affected area.Conclusions: the device was not returned to halyard for evaluation, therefore, we are unable to determine the cause for the reported event.The ifu indicates that the antimicrobial effects of silversoaker catheters has been shown to be active for up to 10 days.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 CATHETER, SILVERSOAKER 7.5IN(19CM)
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): HALYARD - IRVINE, CALIFORNIA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4308571
• MDR Text Key: 5211740
• Report Number: 2026095-2014-00257
• Device Sequence Number: 1
• Product Code: BSO
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• 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: 101354100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• 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: STERI-STRIPS, DERMABOND AND VERSED.; DRUG: ROPIVACAINE 0.2% 750ML, ON-Q PUMP, TEGADERM,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98