BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® ONE USE HOLDER; BLOOD SPECIMEN COLLECTION DEVICE
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Model Number 364815 |
Device Problem
Component Incompatible (1108)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the tube was "extremely snug" in the bd vacutainer® one use holder during use and had to pushed "extremely hard" to fit onto the non-patient end needle in order to draw up blood.This occurred on 3000 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: ""for the past several months, the customer has been noticing that their 16x100 sst tubes, code number 367988, have been extremely snug when used with bd's single-use holder, 364815.Customer is stating that they have to push extremely hard on the tubes, to ensure that they can get on to the back-end needle, so that the vacuum can pull the blood in to the tube.".
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Manufacturer Narrative
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H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.
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Event Description
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It was reported that the tube was "extremely snug" in the bd vacutainer® one use holder during use and had to pushed "extremely hard" to fit onto the non-patient end needle in order to draw up blood.This occurred on 3000 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "for the past several months, the customer has been noticing that their 16x100 sst tubes, code number 367988, have been extremely snug when used with bd's single-use holder, 364815.Customer is stating that they have to push extremely hard on the tubes, to ensure that they can get on to the back-end needle, so that the vacuum can pull the blood in to the tube.".
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