MAUDE Adverse Event Report: VENTEC LIFE SYSTEMS, INC VOCSN PATIENT BREATHING PACKAGE; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	PEDIATRIC, ACTIVE, OXYGEN, BLUE
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: ventec continues to investigate the reported issue.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.
Event or Problem Description
It was reported to ventec that the clear film wall of a breathing circuit had detached from the blue polypropylene spiral portion of the patient circuit (pediatric, active, oxygen, blue) assembly.The reported issue was discovered during incoming inspection.There were no reports of patient involvement associated with the reported event.Section d4 model number, catalog number and lot code reflects the information known about the patient circuit.The udi was unavailable at the time of this submission, therefore section d4 udi is "unknown", and section h4 date of manufacturer will be left blank.
Additional Manufacturer Narrative
Corrected information for supplemental medwatch report 001 ¿ section d4, model # and catalog # of the initial medwatch report stated: prt-00802-000.Section d4, model # and catalog # of the initial medwatch report should have stated: prt-00802-001.New information for supplemental medwatch report 001 ¿ h6: udi information for the patient circuit was confirmed.Section d4, unique identifier (udi) #, and section h4, date of manufacturer, have been updated accordingly.The patient circuit was not returned to ventec for evaluation.As part of its investigation, ventec examined patient circuits that had been returned by the distributor and had the same part number and lot code as this event.Ventec examined those returned patient circuits and observed that the inner clear tubing had delaminated (detached) from its blue spiral reinforcement.The degree of delamination appeared to vary throughout the length of the circuit based on visual observation and tactile handling of the bond.Ventec contacted the contract manufacturer of the product (supplier) regarding the reported issue.The supplier later advised ventec that it had performed an internal investigation and determined that the product was manufactured using inadequate extrusion temperature.Please reference ventec corrections and removals report number 3013095415-12/22/2023-001-r.Ventec was unable to enter and transmit the corrections and removals number in section h9 due to system character limits in that field.H3 other text : not returned to manufacturer.
Additional Manufacturer Narrative
**udi related data quality updates only** corrected information for supplemental medwatch report 002 ¿ section d1, brand name, of the initial medwatch report stated: vocsn.Section d1, brand name, of the initial medwatch report should have stated: vocsn patient breathing package.Section d4, model #, of supplemental medwatch report 001 stated: prt-00802-001.Section d4, model #, of supplemental medwatch report 001 should have stated: pediatric, active, oxygen, blue.Section d4, udi #, of supplemental medwatch report 001 stated: (b)(4).Section d4, udi #, of supplemental medwatch report 001 should have stated: (b)(4).Section h5, labeled for single use, of the initial medwatch report stated: no.Section h5, labeled for single use, of the initial medwatch report should have stated: yes.

• Brand Name: VOCSN PATIENT BREATHING PACKAGE
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VENTEC LIFE SYSTEMS, INC; 22002 26th ave se; bothell WA 98021
• Manufacturer (Section G): VENTEC LIFE SYSTEMS, INC; 22002 26th ave se; bothell WA 98021
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 18288707
• Report Number: 3013095415-2023-00802
• Device Sequence Number: 17816799
• Product Code: CBK
• UDI-Device Identifier: 00855573007587
• UDI-Public: (01)00855573007587(11)220307(10)220922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2023

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: PEDIATRIC, ACTIVE, OXYGEN, BLUE
• Device Catalogue Number: PRT-00802-001
• Device Lot Number: 220922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 07/17/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/04/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: SEE H10
• Patient Sequence Number: 1
• Patient Sex: Unknown