C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned for evaluation.
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Event Description
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It was reported "patient was being heparin locked to de-access today.Side port was cracked and leaking.Verge to follow.This was on the clear disc type port needle again.To be specific it is leaking just below where the syringe attaches, ie the tubing is split open and when it is flushed, the saline comes spurting out.".
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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 0.75¿ safestep safety infusion with y-site.Usage residues were observed throughout the sample and a needleless injection cap was attached to the luer adapter.A partially circumferential split was observed at the proximal luer/tubing joint.Microscopic inspection of the split revealed a granular fracture surface.Beach 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, suggesting that securement, access and maintenance techniques may have contributed; however, it appeared that an additional unidentified factor(s) may have contributed.H3 other text : evaluation findings are in section h.11.
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Event Description
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It was reported "patient was being heparin locked to de-access today.Side port was cracked and leaking.Verge to follow.This was on the clear disc type port needle again.To be specific it is leaking just below where the syringe attaches, ie the tubing is split open and when it is flushed, the saline comes spurting out.".
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Search Alerts/Recalls
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