Catalog Number 105200-000050 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that prior to use, "the device failed to say deflated after the air was removed.The syringe was used to remove the air, removed and [then] make inflated again".No patient involvement.
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Manufacturer Narrative
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(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
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Manufacturer Narrative
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(b)(4).Complaint sample was received at the manufacturing facility.The product was inspected and tested for leak test in water.Result shows that there is leak at the cpv welding area.Based on the complaint description and review of dhr for the affected lot, no abnormalities were identified.There was also no nonconformances raised during the production of the lot.Based on the investigation and the complaint sample received, it was clearly observed that the product was having a leak at the cuff pilot valve (cpv) and concluded that the root cause was "manufacturing related".Therefore, further evaluation shall be recorded in a nonconformance, and the risk assessment shall be completed through risk evaluation.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that prior to use, "the device failed to say deflated after the air was removed.The syringe was used to remove the air, removed and [then] make inflated again".No patient involvement.
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Search Alerts/Recalls
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