Model Number IPN040128 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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Epidural packaging was broken and dented causing the sterility of the inside to be questioned.One of the packages the corner was broken off from the dent.Could not use any of the 3 epidural packages as they were all dented and broken.
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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Epidural packaging was broken and dented causing the sterility of the inside to be questioned.One of the packages the corner was broken off from the dent.Could not use any of the 3 epidural packages as they were all dented and broken.
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Manufacturer Narrative
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Qn#(b)(4).A device history record review was performed on the outer tray and kit with no relevant findings.The customer reported the kit was damaged.The customer returned one damaged kit.Visual examination of the returned kit revealed the lower left corner of the outer tray is damaged under the flange and part of the corner is missing.No other defects or anomalies were observed.The customer also provided photos that appear to show the corner of a kit being damaged (reference files pic1-tc# (b)(4) ).A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.Per the manufacturing site, all incoming outer trays are visually inspected for evidence of stress marks prior to packaging as well as each packaged kit is inspected after sealing and prior to being placed into the corrugate container.The reported complaint the kit being damaged was confirmed based on the sample received.Visual inspection of the returned kit revealed the lower left corner was damaged under the flange and part of the corner was missing.The customer also provided photos that appear to show the corner of a kit being damaged.A device history record review was performed on the outer tray and kit with no relevant findings.Also, the outer trays are 100% inspected prior to and after packaging.It is unknown how the kit was handled during shipping or prior to use.The investigation found no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the tray's corner being damaged could not be determined.
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Event Description
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Epidural packaging was broken and dented causing the sterility of the inside to be questioned.One of the packages the corner was broken off from the dent.Could not use any of the 3 epidural packages as they were all dented and broken.
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Search Alerts/Recalls
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