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

Model Number	QB15016SGC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 24-jun-2021 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 or Problem Description
Procedure: popliteal block and the other an adductor.Cathplace: unknown.It was reported, one of the two catheters was missing the black marker at the catheter tip and the marker before the first hole.The anesthesiologist believes that the catheter was not broken, but is intact.He thinks it was missing the black coloring on the tip, as well as a couple of the increment markers.The patient sent the photo to the nurse, who showed the physician.
Additional Manufacturer Narrative
The sample was not received, however a picture was received with defect reported.A dhr review was not performed because the lot number was not provided.After a process review it was concluded that the defect was not associated with the kitting process, it is a raw material defect, root cause of the defect was deemed to be unknown.All information reasonably known as of 19-aug-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.

• Brand Name: ON-Q PAIN RELIEF SYSTEM QUIKBLOC OVER-THE-NEEDLE CATHETER SET, STIMULATING
• Common Device Name: REGIONAL ANESTHESIA
• MDR Report Key: 12062091
• Report Number: 2026095-2021-00068
• Device Sequence Number: 3800788
• Product Code: BSO
• UDI-Device Identifier: 00193494430597
• UDI-Public: 00193494430597
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: QB15016SGC
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2021
• Supplement Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 08/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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