MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Additional lot numbers with the same problem (0004119552, 0004119552 and 0004114199).

Event Description

It was reported to vyaire medical that the vital signs pediatric anesthesia breathing circuit are coming apart and detaching with small effort at the y connector.There was no patient involvement.

Manufacturer Narrative

Device evaluation: d9, g3, g6, h2, h3,h6 and h10.The device history record for the b1513xxx vital signs® pediatric anesthesia breathing circuit with lot numbers 0004114956, 0004119552, and 0004114199 were reviewed in order to detect any issues related with the defect reported during its manufacture.The complete lots was manufactured, inspected and released per our internal procedures and no issues were found.Based on the investigation and photo analysis, we determine that the assembly personnel could be involved in the reported failure mode, if the circuit is not assembled correctly, a component could disconnect due to a weak assembly.Although quality personnel are trained to perform an inspection looking for poor assembly, missing components, contamination, damaged, as well as leak test.As a corrective and preventive action, all the personnel were re-trained on the correct assembly for the pediatric circuit.

Manufacturer Narrative

The device history record for the b1513xxx vital signs® pediatric anesthesia breathing circuit with lot numbers 0004114956, 0004119552, and 0004114199 were reviewed to detect any issues related with the defect reported during its manufacture.The complete lots were manufactured, inspected, and released per our internal procedures and no issues were found.Based on the investigation and per picture and video provided for investigation, vyaire determine that the manufacturing process is involved in the reported failure mode, if there is no visual help and the implementation of a press to follow and effectuate the correct assembly between both components wye part number r5160ya and tube part number r5108mexa, it could end up with more disconnection issues due to a poor or weak assembly.Although quality personnel are trained on pqas 5161e etal to perform an inspection looking for poor assembly, missing components, contamination, damage, as well as leak testing, this inspection is only a sampling.In addition, pfmea 58a was reviewed, and we have the control for this type of issue.As a corrective and preventive action, there will be an upgrade in the visual aids (jibs) to incorporate the correct way to assemble the component wye part number r5160ya and the tube part number r5108mexa.Besides that, there will be an upgrade to the spm 5161e etal incorporating the exclusive use of press for this particular assembly.These actions would be performed under cmp-2022-0003.In addition, manufacturing personnel were notified about the complaint.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, ; MX
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11577325
• MDR Text Key: 249731398
• Report Number: 8030673-2021-00158
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752123816
• UDI-Public: (01)10190752123816
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: B1513XXX
• Device Lot Number: 0004114956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1