BECTON DICKINSON UNSPECIFIED BD¿ BLUNT CANNULA TRANSFER DEVICE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
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Catalog Number UNKNOWN |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Event Description
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It was reported that the unspecified bd¿ blunt cannula transfer device cored a piece of the vial's stopper into the syringe while withdrawing methylprenisolone.The following information was provided by the initial reporter, translated from french: "core sampling.While withdrawing methylprenisolone 40mg (mylan) using a bd blunt needle (18g*40mm), the nurse saw a core of the septum of the vial in the syringe.Information was collected from one of her colleagues who saw the piece of septum in the syringe, but did not witness the preparation and drawing of the solution.It appears that the technique of percussion of the septum was done in accordance, at 90°.The chemotherapy department informed us yesterday of a problem of coring with the use of a bd blunt needle (18g*40mm), which is currently used instead of the so-called "pumping" needles (the "pink" ones in 18g * 40 mm, ref 304622) in breakage.We had been assured that they are precisely "anti-coring".
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