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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 Improper Flow or Infusion (2954)
Patient Problems Skin Irritation (2076); Numbness (2415)
Event Date 06/13/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record is in-progress.All information reasonably known as of 06 jul 2020 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 avanos medical inc.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 avanos medical inc.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).Device not returned.
 
Event Description
Fill volume: 500 ml, flow rate: 10 ml/hr, 8 ml/hr, 6 ml/hr, procedure: l rotator cuff repair, procedure date: (b)() 2020, cathplace: neck, infusion start time: (b)(6) 2020 1300, infusion stop time: (b)(6) 2020 2100.It was reported that the patient's pump infused in 24 hours.Patient does not have any side effects of fast flow.Patient's wife stated the patient came home with dial at 6ml/hr and during night increased to 10ml/hr.Patient tried to decrease the 8ml/hr in the morning but pain increased so increased back to 10ml/hr.Patient "still numb in arm and fingers." additional information received the same day indicated the patient's wife spoke to a physician who recommended the catheter be removed.Site appeared slightly red and irritated.
 
Manufacturer Narrative
Corrected data: d1 brand name, d4 model number.The device history record for lot 30004422 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Photos of the device were provided by the customer; however, root cause could not be determined.All information reasonably known as of 28 jul 2020 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 avanos medical inc.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 avanos medical inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.
 
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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
MDR Report Key10236416
MDR Text Key242645992
Report Number2026095-2020-00109
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
PMA/PMN Number
K063530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 07/29/2020
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 Lay User/Patient
Device Expiration Date03/27/2022
Device Model NumberCB004
Device Catalogue NumberN/A
Device Lot Number30004422
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/13/2020
Initial Date FDA Received07/06/2020
Supplement Dates Manufacturer Received07/15/2020
Supplement Dates FDA Received07/29/2020
Patient Sequence Number1
Treatment
MARCAINE 0.25%; STINGRAY ADAPTER
Patient Age59 YR
Patient Weight76
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