Catalog Number A-6020-08LF |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that there was a break at the connector.The report states that "the baby was in the winnie palmer nicu, the staff stated that the provider disconnected the pleura vac to reposition the chest tube, once the chest tube was in the correct position, the provider attempted to reconnect the pleura vac and the connection piece broke off inside of the chest tube line.Provider subsequently had to pull out the chest tube and put a new one in.The baby is still in the nicu with a chest tube in place".
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Manufacturer Narrative
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Qn#(b)(4).Customer complaint cannot be confirmed as a manufacturing defect, although provided sample shown a damage at the connector, there is not enough evidence that shows that the damage was caused during the manufacturing process since damage could occurred during transportation or handling of the unit to end user.The device history record has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.However, complaints of this type will continue to be monitored via periodic reviews to evaluate if any trend exists.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that there was a break at the connector.The report states that "the baby was in the winnie palmer nicu, the staff stated that the provider disconnected the pleura vac to reposition the chest tube, once the chest tube was in the correct position, the provider attempted to reconnect the pleura vac and the connection piece broke off inside of the chest tube line.Provider subsequently had to pull out the chest tube and put a new one in.The baby is still in the nicu with a chest tube in place".
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Search Alerts/Recalls
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