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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS 270 ML; KITS

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AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS 270 ML; KITS Back to Search Results
Model Number PM025-A
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/30/2020
Event Type  malfunction  
Manufacturer Narrative
The product involved in the report has been returned, and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18-dec-2020 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: unknown; flow rate: unknown; procedure: abdominoplasty; cathplace: abdomen.It was reported, "the catheter broke off", when the clinician was removing the device from the patient.It was noted the broken device component would be removed from the patient when the incision heals.There was no reported injury.
 
Manufacturer Narrative
The device history record for the reported lot number: 30039240, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One catheter was received in two segments.The device was evaluated and the reported failure was confirmed.A root cause was not identified.All information reasonably known as of 21-jan-2021 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 DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS 270 ML
Type of Device
KITS
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key11046912
MDR Text Key222740882
Report Number2026095-2020-00185
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00193494137182
UDI-Public00193494137182
Combination Product (y/n)N
PMA/PMN Number
K063530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial
Report Date 12/21/2020
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 Health Professional
Device Model NumberPM025-A
Device Catalogue NumberN/A
Device Lot Number30039240
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/21/2020
Patient Sequence Number1
Patient Age52 YR
Patient Weight81
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