MAUDE Adverse Event Report: HALYARD - IRVINE HALYARD* ON-Q* CATHETERS-SILVERSOAKER*

Model Number	PM020-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 02-nov-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: 400 ml.Flow rate: 4 ml/hr.Infusion schedule: was to infuse 85 cc/hr.Procedure: repair hernia incision, laparoscopic incision ventral w/ primary fascia.Reapprox ventralite st 4.5" round mesh sublay placement.Cathplace: rectus diastasis - cath placed bi-lateral subcostal region at level of preperitoneal sac 2 separate epigastric stab incisions, uteral intra-muscular space used for tap block.It was reported that the patient had pain on (b)(6) 2017.On (b)(6) 2017, a computed tomography scan revealed an abdominal abscess.Oh the (b)(6) 2017, the surgeon felt that the issue was caused by the catheter placement.The infection was diagnosed in office after removal of the catheter as "staph aureus present, possible mrsa written in note" and was diagnosed on (b)(6) 2017.The patient had to have an incision and drainage on (b)(6) 2017.The patient's current condition is reported as "good.".

• Common Device Name: CATHETERS
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7004376
• Report Number: 2026095-2017-00192
• Device Sequence Number: 1144736
• Product Code: BSO
• UDI-Device Identifier: 30680651135354
• UDI-Public: 30680651135354
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/17/2017

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
• Operator of Device: Physician
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/06/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 82