C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH 15 CM PRE-CURVE KIT; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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Model Number N/A |
Device Problem
Component Incompatible (1108)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2023 |
Event Type
malfunction
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Event Description
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It was reported in the process of puncturing the needle, after the puncture is successful, the needle cap jams the guide wire when feeding in the guide wire, making it difficult to pass through the puncture needle and it is difficult to withdraw the puncture needle.On (b)(6) 2023 it was found during an investigation the guidewire was stretched and the core wire was damaged.It was reported this occurred with 4 devices.One device was returned for evaluation.This report addresses the device that was returned.
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Manufacturer Narrative
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H11: section a through f - 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 complaint of difficulty advancing the guidewire through the introducer needle is confirmed.One video of a j-tip guidewire and an introducer needle was returned for evaluation.An initial visual observation of the video showed multiple unsuccessful attempts to advance and retract the j-tip guidewire from the needle.It appears the guidewire was stretched when being withdrawn, indicating the core wire was damaged.The j-tip portion of the guidewire was protruding from the distal end of the needle.Evidence of usage residue can be seen on the sample in the returned video.No other obvious details of damage were observed.The guidewire became stuck within the needle following insertion of the wire through the needle, as evidenced by the distal portion of the needle being visible past the tip of the needle.Further, the biological residue suggested that the wire became stuck during attempted device use.Such damage may occur if the wire is withdrawn against the needle bevel following insertion and if the needle is re-inserted following removal or partial removal.
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