Catalog Number AK-11142-D |
Device Problems
Obstruction of Flow (2423); Insufficient Information (3190)
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Patient Problems
Extravasation (1842); Hematoma (1884); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional information: the customer reports the proximal lumen did not have a blood return.It is reported, from the user facility, that the doctor said the hematoma was a result of misplacement of the mac.It is reported that the patient was in critical condition.The user facility reports that the patient was in critical condition prior to use of the device.Ifu provided to sales rep.(to provide to doctor).
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Event Description
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The doctor from the user facility called teleflex cma line.The doctor is the vascular surgeon.An anesthesiologist placed the ak-11142-d (mac cvc).The doctor (vascular surgeon) said the device placed in left subclavian and only got return for one of the 2 lumens.He could not tell where the tip of the mac was specifically.The patient had a large left neck hematoma and bled up the neck.The doctor says the actual device is not available for return and does not know the lot number.His main question was if the mac is contraindicated in the subclavian vein and asked for ifus.
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Event Description
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The doctor from the user facility called teleflex cma line.The doctor is the vascular surgeon.An anesthesiologist placed the ak-11142-d (mac cvc).The doctor (vascular surgeon) said the device placed in left subclavian and only got return for one of the 2 lumens.He could not tell where the tip of the mac was specifically.The patient had a large left neck hematoma and bled up the neck.The doctor says the actual device is not available for return and does not know the lot number.His main question was if the mac is contraindicated in the subclavian vein and asked for ifus.
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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.The lot number was not reported; therefore a device history record review was performed based on a potential lot number from the sales history of the customer.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Search Alerts/Recalls
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