MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE ON-Q PAIN RELIEF SYSTEM QUIKBLOC OVER-THE-NEEDLE CATHETER SET, STIMULATING; REGIONAL ANESTHESIA

Model Number	QB10016SGC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
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 not possible as no lot number was provided.All information reasonably known as of 16-dec-2019 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.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Hold for marcia 4/2 fill volume: unknown.Flow rate: unknown.Procedure: a fascia iliac block for hip fracture.Cathplace: unknown.It was reported a quikbloc needle hub broke off from the base of the needle.There was no reported patient injury reported.Additional information received 26-nov-2019 stated a bolus was given through the needle without incident.There was no patient injury.
Additional Manufacturer Narrative
The sample needle was received and appeared to have visible damage.The sample device was evaluated.The nose piece of the needle hub was observed separated from the needle assembly during sample evaluation.The root cause couldn't be identified since the lot number was not available to conduct the production documentation review.All information reasonably known as of 28-feb-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.

• Brand Name: ON-Q PAIN RELIEF SYSTEM QUIKBLOC OVER-THE-NEEDLE CATHETER SET, STIMULATING
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9489438
• Report Number: 3006646024-2019-00032
• Device Sequence Number: 19302074
• Product Code: BSO
• UDI-Device Identifier: 10680651430561
• UDI-Public: 10680651430561
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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
• Operator of Device: Health Professional
• Device Model Number: QB10016SGC
• Device Catalogue Number: 104305701
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/29/2020
• Patient Sequence Number: 1