Model Number 29420 |
Device Problems
Contamination (1120); Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.
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Event Description
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It was reported that a device contamination occurred.A 135/20 renegade hi-flo catheter was selected for use.During preparation, it was noted that the packaging was not sealed and the sterility of the device was compromised.The procedure was completed with another of same device.No complications were reported and patient was stable post procedure.
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Event Description
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It was reported that a device contamination occurred.A 135/20 renegade hi-flo catheter was selected for use.During preparation, it was noted that the packaging was not sealed and the sterility of the device was compromised.The procedure was completed with another of same device.No complications were reported and patient was stable post procedure.
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Manufacturer Narrative
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A2 - age at time of event: 18 years or older.Device evaluated by mfr: the device with its packaging has been received for analysis.The outer box seal was broken, and the inner pouch had been opened (across the top of the pouch and down halfway of the right side).Along the top of the pouch were residue signs that it had been sealed and pulled open.The device itself was in the shipping hoop and showed no signs of use.The residual of the sealing process on the pouch confirms the pouch had been sealed at one time.
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Search Alerts/Recalls
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