MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,600X2-14,CB SAF,-,OQ,5; ELASTOMERIC - SAF

Model Number	CB6004
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.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: 600 ml; flow rate: 8 ml/hr; procedure: right knee scope; cathplace: groin.Pump start time and date: (b)(6) 2016 8:59 am.Pump end time and date: (b)(6) 2016 1:00 am.It was reported that a patient woke up in the middle of the night and noticed that the pump was empty.There were no reported adverse effects.No further information was provided.
Additional Manufacturer Narrative
(b)(4).The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 01may2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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.(b)(4).

• Brand Name: SURGPN,600X2-14,CB SAF,-,OQ,5
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 6247206
• Report Number: 2026095-2017-00006
• Device Sequence Number: 10995248
• Product Code: MEB
• UDI-Device Identifier: 10680651134766
• UDI-Public: 10680651134766
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/20/2019
• Device Model Number: CB6004
• Device Catalogue Number: 101347600
• Device Lot Number: 0202547280
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 05/02/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.2% ROPIVACAINE
• Patient Age: 44 YR
• Patient Weight: 98