MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q C-BLOC INTL PAIN RELIEF SYSTEM WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number	CBI006
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for lot 0202880158 was reviewed and the product was produced according to product specifications.All information reasonably known as of 11 jul 2018 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 halyard health 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 halyard health.Halyard health 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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
Fill volume: unknown; flow rate: 10ml/hour; procedure: unknown; cathplace: unknown; infusion start time: unknown; infusion stop time: unknown.It was reported that the bolus button was not working, and was delivering 5ml of unknown local anesthetic every 8 minutes, instead of every 30 minutes.The patient reported the issue to the nurse.Per additional information received 22 jun 2018, the priming tab was removed, the bolus indicator was in the top position, and the bolus button became stuck.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of (b)(6) 2018 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 halyard health 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 a avanos medical inc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
The sample was received and evaluated.The evaluation concluded that a fast flow rate was not observed.Limited information was provided in regards of the use of the product.Fill volume information was not available nor the user or facility conditions.It could not be determined if the use conditions were contributors to the reported incident.The medication is not a potential contributor to the incident of fast flow.Root cause could not be determined since the device worked as intended during sample evaluation.Additionally, dhr review found no abnormal conditions that could have contributed to the reported incident.All information reasonably known as of (b)(6) 2018 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 halyard health 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 a avanos medical inc.Product is defective or caused serious injury.

• Brand Name: ON-Q C-BLOC INTL PAIN RELIEF SYSTEM WITH SELECT-A-FLOW AND ONDEMAND
• Common Device Name: ELASTOMERIC - COMBO
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7690117
• Report Number: 2026095-2018-00077
• Device Sequence Number: 2771231
• Product Code: MEB
• UDI-Device Identifier: 30680651134838
• UDI-Public: 30680651134838
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2018

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
• Operator of Device: Other
• Device Expiration Date: 12/25/2019
• Device Model Number: CBI006
• Device Catalogue Number: 101348303
• Device Lot Number: 0202880158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 11/02/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 09/06/2018; 11/20/2018
• Patient Sequence Number: 1