MAUDE Adverse Event Report: AVANOS MEDICAL INC. SURGICAL PAIN; ELASTOMERIC - ON-Q WITH BOLUS

Model Number	CB006C
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Fill volume: 550 ml.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.Infusion start time: unknown.Infusion stop time: unknown.The fellow reported on post operation day, the ball was only 1/3 full and they noticed the bolus button was stuck in the 1/2 down position, causing a possible fast flow.There was no reported injury.Additional information received 13jul2022 reported, the pump was pulled post op day one and replaced with a new pump; there was no reported injury.
Additional 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 02 aug 2022 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 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.
Additional Manufacturer Narrative
The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed: there was no visible crystallization or discoloration on the filter, the fill port cap was attached, there was no cap on the distal luer, the tubing was intact with no visible damage, the dial was present, the cover was secured with the zip tie and the bolus indicator was between the mid-point and full.Testing of the sample: the pump was drained of the remaining medication and refilled to the reported volume of 550ml, infusion was observed at the distal luer; the pump yielded a flow rate within specification.At the end of flow accuracy testing, the bolus moved back to the ¿full¿ indicator, the button was fully in the ¿up¿ position and the button was depressed and was heard to latch; no failure was observed.During testing, the scale showed increasing weight after being zeroed during the 20 and 10-minute fill periods for bolus button volume and safety testing; this indicated that the fast flow was caused by a leak in the bolus into the tubing.The reported event couldt be confirmed as reported; the root cause is operator error.The device history record for lot 30160339 was reviewed and the product was produced according to product specifications.All information reasonably known as of 04 oct 2022 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 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: SURGICAL PAIN
• Common Device Name: ELASTOMERIC - ON-Q WITH BOLUS
• 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: 15182825
• Report Number: 2026095-2022-00086
• Device Sequence Number: 17727670
• Product Code: MEB
• UDI-Device Identifier: 00193494468576
• UDI-Public: 00193494468576
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: Health Professional
• Device Expiration Date: 05/22/2024
• Device Model Number: CB006C
• Device Catalogue Number: N/A
• Device Lot Number: 30160339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .2% ROPIVACAINE
• Patient Age: 73 YR
• Patient Sex: Female