Catalog Number UNKNOWN |
Device Problem
Short Fill (1575)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It has been reported that the unspecified bd¿ containment tube has been found experiencing underfill during use.The following has been provided by the initial reporter: material no.Unknown batch no.Unknown.It was reported that tubes would not fill properly.Customer noted when she tried to fill the tube, the blood was stopped halfway.She used approx.5 or 6 from the box and all were defective.
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Event Description
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It has been reported that the unspecified bd¿ containment tube has been found experiencing underfill during use.The following has been provided by the initial reporter: material no.Unknown; batch no.Unknown.It was reported that tubes would not fill properly.Customer noted when she tried to fill the tube, the blood was stopped halfway - she used approx.5 or 6 from the box and all were defective.
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Manufacturer Narrative
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Investigation summary: the customer did not provide bd pas with product catalog number or lot number information, when requested.After 3-follow-up attempts to obtain additional information, bd pas has closed this customer complaint.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.
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Search Alerts/Recalls
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