MAUDE Adverse Event Report: HALYARD - IRVINE ECHOLONG CONTINUOUS NEEDLE & CATHETER SET; REGIONAL ANESTHESIA

Model Number	ELL18100TGC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.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 10-apr-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).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 halyard health product is defective or caused serious injury.Device not returned.
Event or Problem Description
Fill volume: n/a.Flow rate: n/a.Procedure: total knee arthroplasty.Cathplace: adductor canal block.It was reported that a catheter sheered at the end of february, possibly the (b)(6).Difficultly was experienced when trying to pass the catheter through the needle.Resistance was met and the catheter was pulled back, then advanced again.This was repeated without success.The catheter and needle were removed and it was found that the catheter's black tip sheered completely off.The needle was discarded, but the catheter was retained.An x-ray was performed, but the catheter tip could not be visualized on the image.No further action was taken and no patient injury was reported.Additional information received on 10-apr-2018 stated that the sample was disposed of.

• Brand Name: ECHOLONG CONTINUOUS NEEDLE & CATHETER SET
• Common Device Name: REGIONAL ANESTHESIA
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• MDR Report Key: 7426061
• Report Number: 2026095-2018-00048
• Device Sequence Number: 13882143
• Product Code: CAZ
• UDI-Device Identifier: 30680651392283
• UDI-Public: 30680651392283
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K111355
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: Health Professional
• Device Model Number: ELL18100TGC
• Device Catalogue Number: 103922800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/12/2018
• Patient Sequence Number: 1