MAUDE Adverse Event Report: LIMB--O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Model Number LIMB--O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT

Device Problem Material Puncture/Hole (1504)

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

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

Event Description

The customer reported several issues with the amn520x4f limb--o¿ single limb anesthesia breathing circuit "failing" while in a procedure.There was no patient harm reported.

Manufacturer Narrative

Additional information: h4.Device evaluation: g3, g6, h2, h3, h6 and h10.Results of investigation:the device history record of the p/n amn520x4f with lot number 0004168617 and udi code (b)(4) was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.The complete lot was manufactured on 13nov2020 per our internal procedures and no issues were found.According to the investigation, we determine that the personnel are related to the reported defect, since they must put in the scrap the green bag trapped by the sealing machine according to procedure spm afm1qxxx etal.As a corrective and preventive action, personnel involved were retrained on spm afm1qxxx etal to carry out the proper segregation of the components.

• Brand Name: LIMB--O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• MDR Report Key: 11980122
• MDR Text Key: 264986052
• Report Number: 8030673-2021-00173
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752122987
• UDI-Public: (01)10190752122987(10)000416008617
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

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
• Device Operator: Health Professional
• Device Model Number: LIMB--O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: AMN520X4F
• Device Lot Number: 0004168617
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2020
• 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