Model Number 28211 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that device contamination occurred.A 10frx11cm super sheath introducer sheath was selected for use.Upon unpacking, it was noted that the primary packaging was open.The secondary packaging was sealed but the device was not used as it has lost its sterility.The procedure was completed with a different device.There were no patient complications were reported.
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Event Description
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It was reported that device contamination occurred.A 10frx11cm super sheath introducer sheath was selected for use.Upon unpacking, it was noted that the primary packaging was open.The secondary packaging was sealed but the device was not used as it has lost its sterility.The procedure was completed with a different device.There were no patient complications were reported.
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Manufacturer Narrative
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E1: initial reporter facility name (b)(6).E1: initial reporter address 1- (b)(6).Device evaluated by manufacturer: the device was not returned for analysis.The actual item was not returned, but photos were provided.From an investigation of the provided photo, it was confirmed that the sealed part on the opposite side of the opening mouth of the sterile bag was open.An adhesive mark was observed on the part of the sterile bag where the seal was open.
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Event Description
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It was reported that device contamination occurred.A 10frx11cm super sheath introducer sheath was selected for use.Upon unpacking, it was noted that the primary packaging was open.The secondary packaging was sealed but the device was not used as it has lost its sterility.The procedure was completed with a different device.There were no patient complications were reported.
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Manufacturer Narrative
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E1: initial reporter facility name - (b)(6).E1: initial reporter address 1- (b)(6).Device evaluated by manufacturer: the device was returned for analysis.One set of packaging with a sheath in it was returned.Actual returned product was investigated, and it was confirmed that the central part of the seal part on the opposite side of the opening mouth of the sterile bag was open.Seal marks were found on the part where the seal of the sterile bag was peeled off.It was also confirmed that the part where the seal remains was firmly welded.Welding peel strength of the part where the seal remains was measured, and it was confirmed that it was above the standard value.
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Search Alerts/Recalls
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