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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF

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AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF Back to Search Results
Model Number CB004
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2018
Event Type  malfunction  
Manufacturer Narrative
The actual complaint product was not returned for evaluation.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 11-dec-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc 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 avanos medical inc complaint database and identified as complaint (b)(4).
 
Event Description
Fill volume: 400 ml, flow rate: 8 ml/hr, procedure: unknown, cathplace: unknown.It was reported via fda medwatch mw5081190: "onq pump filled with ropivacaine 0.2% 400 ml x2.Pumps dispensed on (b)(6) 2018 at around 1000.Orders profiled in computer as 8ml/hr or each pump on 2018 at 1100.Pt's rn stated that the pump on the right side was empty.Surgeon was made aware and clamped the pump.Lot number of the clamped pump is 02083660.Date of use 2018.Is the product compounded? yes.Is the product over the counter? no." no patient injury reported.
 
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Brand Name
ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR
Type of Device
ELASTOMERIC - SAF
Manufacturer (Section D)
AVANOS MEDICAL - IRVINE
43 discovery
suite 100
irvine CA 92618
Manufacturer (Section G)
AVENT S. DE R.L. DE C.V.
ave noruega edificio d-1b
fraccionamiento rubio
tijuana b.c. 22116
MX   22116
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta 30004
4704485444
MDR Report Key8158595
MDR Text Key131311594
Report Number2026095-2018-00165
Device Sequence Number1
Product Code MEB
UDI-Device Identifier30680651476068
UDI-Public30680651476068
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/27/2018
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
Device Operator Health Professional
Device Expiration Date04/15/2020
Device Model NumberCB004
Device Catalogue Number101347203
Device Lot Number020836602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/27/2018
Initial Date FDA Received12/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2017
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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