C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2021 |
Event Type
malfunction
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Event Description
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It was reported "bard needle set, the tubing cracked near the connection sleeve and my patient bled out approx.15ml and lost some medication at well.Date of initial access with this needle was (b)(6) 2021 @ 1830.Noticed to be leaking on (b)(6) 2021 @ 2050.When attempting to re access the port, line infiltrated and became so swollen that a piv was needed to continue fluids.Micofungin was the medication infusing at the time of the leak.".
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged infusion set was confirmed.The product returned for evaluation was one 20ga x 1¿ powerloc max safety infusion set.Usage residues were observed throughout the sample.A needleless injection cap was attached to the luer adapter and the safety mechanism was engaged.A partially circumferential split was observed at the luer/tubing joint.Microscopic inspection of the split revealed a granular fracture surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Material buckling and discoloration were observed in the vicinity of the split.The split characteristics and material buckling were consistent with material failure due to repetitive stress.It appeared that the tubing fractured, in part, due to repetitive torsional (twisting) stress; however, an additional unidentified factor(s) also contributed.The supplier has been notified of this event.
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Event Description
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It was reported "bard needle set, the tubing cracked near the connection sleeve and my patient bled out approx.15ml and lost some medication at well.Date of initial access with this needle was (b)(6) 2021 at 1830.Noticed to be leaking on (b)(6) 2021 at 2050.When attempting to re access the port, line infiltrated and became so swollen that a piv was needed to continue fluids.Micofungin was the medication infusing at the time of the leak.".
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