MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q C-BLOC WITH SELECT-A-FLOW AND ONDEMAND 400ML; ELASTOMERIC - COMBO

Model Number CB006

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Fill volume: unknown, flow rate: unknown, procedure: unknown, cathplace: unknown.It was initially reported "bolus button staying decompressed.The button was stuck down, and could not initially get it back up.Going as far as smacking it a few times with a stapler.The button was down, the chamber was indicating it was full, so the user tried letting the chamber run out allowing the button to pop back up.The button only pops back up when the chamber empties, but given the time it took to call a nurse and get the pain team over (likely hours).There was no reported injury.

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 20-apr-2023 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.

Manufacturer Narrative

The device history record for the reported lot number, 30172559, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The pump was received filled, with the pinch clamp present and open.The fill port cap was attached.There was a non-avanos cap on the distal luer.There was no visible crystallization or discoloration on the filter.The tubing was intact, with no visible damage.The select-a-flow (saf) was set to 8.The dial was present.The cover was not secured with the zip tie.The bolus indicator was at the full position.The bolus button appeared to be fully upright.The device was evaluated.Flow accuracy testing was performed, and the results noted the device was within specification, with a +/-20% tolerance.The safety volume test result yielded an average delivery amount which was within specification.At each dispensing, the bolus button latched when depressed and popped back up upon completion.Root cause could not be determined.All information reasonably known as of 13-jun-2023 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.

• Brand Name: ON-Q C-BLOC WITH SELECT-A-FLOW AND ONDEMAND 400ML
• Type of Device: ELASTOMERIC - COMBO
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16784615
• MDR Text Key: 313952423
• Report Number: 2026095-2023-00054
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494134747
• UDI-Public: 00193494134747
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

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 Date: 01/24/2024
• Device Model Number: CB006
• Device Catalogue Number: N/A
• Device Lot Number: 30172559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male