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

Model Number QB10016SGC

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

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 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.

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
• Type of Device: REGIONAL ANESTHESIA
• Manufacturer (Section D): AVANOS MEDICAL - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 9489438
• MDR Text Key: 187017047
• Report Number: 3006646024-2019-00032
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10680651430561
• UDI-Public: 10680651430561
• Combination Product (y/n): N
• PMA/PMN Number: K143164
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/29/2020
• Patient Sequence Number: 1