VYAIRE MEDICAL INC. VITAL SIGNS PEDIATRIC ANETHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Model Number ANES CIRCUIT, PED, 108 IN EXP, 1L BAG |
Device Problems
Leak/Splash (1354); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.The issue was identified with two of the pediatric circuits.Please see (b)(4).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
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Event Description
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It was reported to vyaire medical that the b1714xxx -anes circuit, ped, 108 in exp, 1l bag has holes in the circuit causing an air leak.The product was in the process of being attached to the patient when the damage was found.It was noticed when the tubing was extended and the anesthesia gas began to leak.A new circuit was obtained and used in place of the faulty product.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
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Search Alerts/Recalls
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