MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q SILVERSOAKER 5IN(12.5CM)400ML DUAL 2+2; ELASTOMERIC PUMP

Model Number PM028-A

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

Patient Problems Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930)

Event Date 12/24/2014

Event Type  Injury  

Event Description

Procedure: tah/ laparoscopic cholecystectomy.Cathplace: tunneled from left to right at pfannenstiel incision.It was reported that a patient experienced a catheter site infection, manifested by fever, redness and purulent drainage from the catheter tract while using an on-q pump with a silversoaker catheter.Therefore, please reference: 2026095-2015-00014/14-01160 for the pump.Device #2 of 2: the patient indicated that the pump was inserted after surgery on (b)(6) 2014.The patient reported that the catheter site was leaking clear fluid; therefore, on (b)(6) 2014 the patient returned to the hospital and the "nurse sterilely applied dermabond to the catheter site and a new dressing to the catheter site".The patient reported that there was no redness, pain or swelling at the surgical site until the catheter was removed on "day 5".The patient "removed the catheter and purulent drainage was observed coming from the catheter tract.2026095-2015-00015/14-01165.The patient then noticed redness and the patient developed a fever.The patient was on a course of antibiotics and stated no adverse effects.The patient was treated with antibiotics (keflex, augmentin and doxycycline).The patient reported that the fever and infection have cleared, however a small area about 2 inches of the pfannenstiel incision is still open.The wound was reported as "moist, pink and clean with granulating tissue".The patient is doing wet to dry dressing several times a day.

Manufacturer Narrative

Method: a device was received.The evaluation of the device is anticipated, but not yet begun.A review of the device history record (dhr) was conducted for the reported model and lot number.Results: there are no testing results available as the analysis of the device cannot confirm the cause of the infection.Post-operative infection can be due to multiple variables.The dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related non conformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.In addition, the sterilization certificate indicates that the lot passed and was found to be in conformance with all specified requirements for sterile products.Conclusions: as a 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, environment factors are a few variable to consider.The patient reported that no culture was performed to confirm the diagnosis of infection.The sterilization certificate indicated that the lot passed and was found to be in conformance with all specified requirements for sterile products.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 SILVERSOAKER 5IN(12.5CM)400ML DUAL 2+2
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4469199
• MDR Text Key: 18927471
• Report Number: 2026095-2015-00015
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2014

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 Expiration Date: 11/30/2015
• Device Model Number: PM028-A
• Device Catalogue Number: 101372100
• Device Lot Number: 0201049847
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2014
• Initial Date FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• 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: MARCAINE 0.5%; ON-Q PUMP-MODEL #P400X5
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 58