Catalog Number UNKNOWN |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2023 |
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 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.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using an unspecified bd syringe the plunger fell out.This is report 4 of 6.There was no report of patient impact.The following information was provided by the initial reporter: we continue to see issues in one area of our hospital (all different staff involved) and the plunger is removed when the tamper packaging is opened.Education/videos/rounds have been completed as well, re: properly opening the packaging.(b)(6) 2023: -could you please advise the occurrence date? (b)(6) 2023.-what is the material and batch number of the affected product? unsure.-is there any adverse event on patient? no.-do you have photo of the faulty product? no.-is sample available for return? if yes, please provide address for return label.No.-i do not have any batch numbers.
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Event Description
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It was reported while using an unspecified bd syringe the plunger fell out.This is report 4 of 6.There was no report of patient impact.The following information was provided by the initial reporter: we continue to see issues in one area of our hospital (all different staff involved)and the plunger is removed when the tamper packaging is opened.Education/videos/rounds have been completed as well, re: properly opening the packaging.15 aug 23 -could you please advise the occurrence date? 4/24/23, 5/2/23, 6/16/23, 6/20/23, 6/29/23, 7/27/23 -what is the material and batch number of the affected product? unsure-@xxxx? -is there any adverse event on patient? no -do you have photo of the faulty product? no -is sample available for return? if yes, please provide address for return label.No -i do not have any batch numbers.
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Manufacturer Narrative
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H6: 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.A device history review could not be completed as no batch number was provided.Based on the limited investigation results, a cause for the reported incident could not be determined.
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Search Alerts/Recalls
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