C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM PRE-CURVED SHORT-TERM DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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Model Number N/A |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2023 |
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 manufacturer has received the sample and will evaluate.Results are expected soon.
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Event Description
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It was reported that, "on monday, (b)(6), the placement of a 15cm, 13.5 fr niagara catheter is scheduled for insertion.At the time of puncture, it is observed that there is no hermetic seal between the needle and the syringe because adequate suction is not observed after the puncture, which it is necessary to obtain venous return from the vessel to which one wishes to access, when aspirating the solution and pressing the plunger, a leak is observed between it, it is decided to use another new 20 cm catheter, 13.5 fr, however, the same situation occurs, different syringes are used both 5cc and 10cc sterile without obtaining adequate functionality, so the procedure is suspended." additional information received on may 18, 2023: the patient could not receive his treatment, due to the problem presented.This report addresses the first insertion attempt with a15 cm catheter.
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Event Description
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It was reported that, "on monday, (b)(6), the placement of a 15cm, 13.5 fr niagara catheter is scheduled for insertion.At the time of puncture, it is observed that there is no hermetic seal between the needle and the syringe because adequate suction is not observed after the puncture, which it is necessary to obtain venous return from the vessel to which one wishes to access, when aspirating the solution and pressing the plunger, a leak is observed between it, it is decided to use another new 20 cm catheter, 13.5 fr, however, the same situation occurs, different syringes are used both 5cc and 10cc sterile without obtaining adequate functionality, so the procedure is suspended." additional information received on may 18, 2023: the patient could not receive his treatment, due to the problem presented.This report addresses the first insertion attempt with a15 cm catheter.
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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 unable to aspirate is confirmed but the exact cause remains unknown.One video sample of an 18 ga introducer needle attached to a syringe was provided for evaluation.The user is attempting to aspirate fluid within a bowl; however, no liquid is found to aspirate.When fluid is infused through the needle, the fluid is found to leak at the hub.The characteristics of the damage could not be inspected from the video provided.Based on the information provided, possible contributing factors include damage during handling and over-tightening.Since a hub leak was observed, the complaint is confirmed but the exact cause remains unknown.H3 other text: evaluation findings are in section h11.
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