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	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.The device history record for the reported lot number, 0202876302, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 01-mar-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.(b)(4).
Event or Problem Description
Fill volume: n/a, flow rate: n/a, procedure: right total knee, cathplace: adductor canal.It was reported that a catheter broke during an adductor canal block procedure on (b)(6) 2018.The broken fragment remained in the patient.Additional information received on 26-feb-2018 stated that 9.5 cm of the catheter broke off and was retained in the patient during initial removal, which was attempted by hand.Surgical removal was attempted on the retained portion of the catheter.The patient experienced discomfort, but the broken piece was noted as not removed.No further information was received.
Additional Manufacturer Narrative
Halyard health received one sample.A visual inspection found a t-block catheter received with the distal infusion section of the tip missing.The tip of the catheter was observed under magnification.A gouge mark was observed proximal to the end of the catheter.The tip of the catheter had sharp edges indicating that a sharp object had been used.Tensile strength was performed on the catheter using the instron machine.The passing rate for the test is >2.8(lbf) at the infusion segment and >4.00 (lbf) for the mid-body segment.The result for the catheter mid-body segment is 6.55(lbf).The infusion segment was not able to be tested as it was not returned.The evaluation summary concludes that the catheter was cut with some type of sharp object.The gouge mark that is present proximal to the cut end indicates that the catheter may have been advanced passed the tip of the needle and then retracted.Tensile strength was performed on the mid-body segment and met specifications.Root cause could not be determined.All information reasonably known as of 18-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).

• 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: 7320451
• Report Number: 2026095-2018-00030
• Device Sequence Number: 1605971
• Product Code: CAZ
• UDI-Device Identifier: 30680651392283
• UDI-Public: 30680651392283
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: Nurse
• Device Expiration Date: 12/13/2020
• Device Model Number: ELL18100TGC
• Device Catalogue Number: 103922803
• Device Lot Number: 0202876302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/20/2018
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 94