C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2023 |
Event Type
malfunction
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Event Description
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It was reported by the customer port needle exposed in packaging.Needle missing protective cover when package opened.No one punctured.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.H3 other text : device not returned for evaluation.
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Event Description
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It was reported via medwatch "port needle exposed in packaging.Needle missing protective cover when package opened.No one punctured." 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 complaint of a missing needle protective cover is inconclusive due to poor sample condition.One 19 ga x 1 in miniloc infusion set was returned in open packaging indicating lot: asgzfc145.The safety mechanism was not activated.The needle protective cover was not observed on the device or within the open packaging.Microscopic inspection of the clear packaging film revealed what appeared to be a puncture.The condition of the device and packaging prior to handling and opening is unknown.Based on the information provided, possible contributing factors include dislodgement of the needle cover during handling and omission during assembly.Since the condition of the device prior to opening remains unknown, the complaint could not be confirmed and remains inconclusive at this time.H3 other text : evaluation findings are in section h.11.
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