MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYNTUS; TWINTUBE COLLECTION TUBE

Model Number	TWINTUBE SAMPLE LINE 240CM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).At this time, vyaire has received the suspect device/component for evaluation.It was found that the exchange broken connector at sample line.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire that the little clear tube at the end of the twintube collection sample line broke off.This is close to the patient's face, where they are breathing through a mask.There is risk of part being aspirated or ingested.The customer confirmed that there was no patient harm associated with this reported event.
Additional Manufacturer Narrative
Corrected data: d9 - date device returned to manufacturer.Vyaire medical file identification: (b)(4).Device evaluation: d9, g3, g6, h2, h10.The component was visually inspected.It was recognized that the white tube had fallen out and was not attached.Inspection showed that the white tube was not glued correctly.Patient risk to swallow the plastic part is very limited because the dvt is inserted in a face mask.The risk for a patient to swallow the part is very low as it would drop and rest in the mask.Additionally, in the case of a spirometry without a mask, a microgard ii filter must be used which is directly connected between the patient and the dvt.It was determined that the root cause for the reported issue was the white tube was not glued correctly.The manufacturer was unable to determine a reason as to why the white tube was not glued correctly.

• Brand Name: VYNTUS
• Common Device Name: TWINTUBE COLLECTION TUBE
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7 hoechberg, 97; hoechberg, 97204 ; GM 97204
• MDR Report Key: 11016345
• Report Number: 9615102-2020-00117
• Device Sequence Number: 869748
• Product Code: BZC
• UDI-Device Identifier: 14250892901432
• UDI-Public: (01)14250892901432(10)201804101400
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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: TWINTUBE SAMPLE LINE 240CM
• Device Catalogue Number: V-707327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1