BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number F320088T |
Device Problems
Retraction Problem (1536); Sticking (1597); Failure to Advance (2524)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rebv1415 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported powerglide pro 8 cm 20 gauge catheter inserted into a patient.After vein accessed, the guidewire advanced with no problem, when the catheter advanced it only advanced halfway.Retracted the catheter and attempted to retract the guidewire but it was stuck in the advanced position.The entire midline pulled out of the patients skin and the guidewire had sheared, uncoiled, and the uncoiled portion was sticking out of the patient¿s skin.Sheared portion of the guidewire was then completely removed.There was no patient injury reported.
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