C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2023 |
Event Type
malfunction
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Event Description
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It was reported that after injecting the drug into the patient, the base came off the from needle when the patient flushed and removed the dressing tape.There was no reported patient injury.No other information was provided.
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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 device has not been returned to the manufacturer for evaluation.
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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 safety mechanism detachment was confirmed and the cause was use related.The product returned for evaluation was one 22g safestep infusion set.Usage residues were observed throughout the sample.The safety mechanism was fully detached from the assembly and was received loose.The sleeve inner diameter was measured using a digital microscope and found to be 0.0290in.Which is within specification.The needle shaft outer diameter was measured using digital calipers and found to be 0.0280in.Which is within specification.Microscopic inspection of the needle found that scoring marks were present throughout the length of the needle.Given the presence of these markings and the fact that the measured components were within specification it is likely that the safety plate was forcefully removed during use.H3 other text : evaluation findings are in section h.11.
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Event Description
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It was reported that after injecting the drug into the patient, the base came off the from needle when the patient flushed and removed the dressing tape.There was no reported patient injury.No other information was provided.
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Search Alerts/Recalls
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