Catalog Number SAC-00820 |
Device Problems
Device Damaged Prior to Use (2284); Material Deformation (2976)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).The preliminary evaluation of the returned device indicates the arterial - swg kinked in package.
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Event Description
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Customer reported that "no patients involved.For jci reasons the arterial catheters can't be stocked any longer in the cardboard box.As the catheters aren't packed in a hard cover tray (= it a floppy pocket), some catheters got kinked.Probably this is a stocking issue and not a complaint.However , it might be interesting to check if the above-mentioned lot number is more susceptible for the kinking of the catheter as this happened 3 times (catheters of the same box?).".
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Manufacturer Narrative
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Qn#(b)(4).Corrected data: results code corrected to (b)(4).
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Event Description
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Customer reported that "no patients involved.For jci reasons the arterial catheters can't be stocked any longer in the cardboard box.As the catheters aren't packed in a hard cover tray (= it a floppy pocket), some catheters got kinked.Probably this is a stocking issue and not a complaint.However , it might be interesting to check if the above-mentioned lot number is more susceptible for the kinking of the catheter as this happened 3 times (catheters of the same box?).".
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Manufacturer Narrative
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Qn#(b)(4).The customer returned one arterial spring wire guide (swg) and lidstock for investigation.Visual analysis revealed that the guide wire contained one distinct kink.Microscopic examination revealed a white stress mark on the tubing at the same location as the kink on the guide wire when fully inserted.The lidstock also had a crease over the location of the kink when the swg was placed within the packaging.The damage observed is consistent with defects related to shipping and handling of other sac sets.No other defects or anomalies were observed.The kink in the guide wire measured 315mm from the proximal tip.The guide wire outer diameter measured 0.510mm, which is within the specification limits of 0.508mm-0.533mm per the guide wire product drawing.The guide wire length measured 351mm, which is within the specification limits of 345mm-355mm per the guide wire product drawing.A device history record review was performed on the kit packaging and the guide wire and no relevant issues were identified.The lidstock was reviewed as part of this complaint investigation.The words "do not bend" are clearly visible on the front of the lidstock.An engineering change order was implemented in (b)(6)2017 to update the product labeling to clearly inform the customer to not bend the product and is intended to reduce the potential for product damage.The reported complaint that the guide wire was found kinked prior to use was confirmed through visual inspection of the returned sample.The returned guide wire contained one distinct kink.The guide wire tubing also contained a stress mark right over the location where the kink in the guide wire is located when fully inserted into the tubing.The lidstock also had a crease over the location of the kink when the swg was placed within the packaging.The words "do not bend" are clearly visible on the front of the lidstock, which is intended to heighten customer awareness and mitigate the risk of kinking the components during storage and shipping of this product.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer description and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Customer reported that "no patients involved.For jci reasons the arterial catheters can't be stocked any longer in the cardboard box.As the catheters aren't packed in a hard cover tray (= it a floppy pocket), some catheters got kinked.Probably this is a stocking issue and not a complaint.However , it might be interesting to check if the above-mentioned lot number is more susceptible for the kinking of the catheter as this happened (b)(4) times (catheters of the same box?).".
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Search Alerts/Recalls
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