C.R. BARD, INC. (BASD) -3006260740 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problem
Material Deformation (2976)
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Patient Problem
Hematoma (1884)
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Event Date 08/03/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refz1147 showed three other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).Device not returned.
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Event Description
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It was reported during the procedure, the guide bent, making it impossible to use the device correctly and putting staff and patient at risk (resulting in bilateral haematoma and impracticability of repositioning in the short term), failing to place midline cvc was used.It was reported this occurred with four devices.This report addresses the third device.
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Search Alerts/Recalls
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