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

Model Number AL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT

Device Problem Disconnection (1171)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).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.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

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 information on patient involvement.

Manufacturer Narrative

] the device history record of the p/n b1513xxx with lot number 0004114956, 0004119552, 0004114199 were reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.The complete lots were manufactured on 04oct19, 11nov2019, 23sep2019 per our internal procedures and no issues were found.According to investigation, we determined that manufacturing personnel are related to reported defect, as they must assemble all components according to our internal procedures to void disconnections like reported on this complaint.In additional, we need the sample to know if there is a dimensional issue on the components.

• Brand Name: VITAL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12701525
• MDR Text Key: 278613111
• Report Number: 8030673-2021-00206
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752123816
• UDI-Public: (01)10190752123816(10)0004114956
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AL SIGNS® PEDIATRIC ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: B1513XXX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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