The manufacturing location for this product is unknown.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.Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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It was reported that a handful of unspecified bd¿ catheter had vent cap were loose closure.Customer¿s verbatim: ¿ there is another product number and lot number, but i do not have that information as i write this e-mail so will update this e-mail when i receive that additional information.I collected a handful of products from the customer where the vent cap is present, but loose in the packaging.The customer would like me to send these in for evaluation.Please let me know how and where to send them.Thank you in advance for your help! ¿.
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Investigation summary: dhr: the lot number was built / packaged on nfa line 1 from 22dec18 thru 23dec18 for a quantity of (b)(4) units.No qns were initiated during production.All challenge, set up and in process inspections were performed according the control plan.Received 2 nexiva 20ga units within sealed packages from lot number 8354797.All contents within were present.Visual/microscopic evaluation: the vent plug was flowing loosely inside the sealed packages of the received units.Conclusion: design: the defect subject of this investigation is a known issue.The vent plug is inserted into the luer adapter at a specified force in manufacturing, when the nexiva product goes through sterilization the fit between the vent plug and luer adapter becomes loose due to material relaxation.
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B.5.Describe event or problem: it was reported that a handful of bd¿ nexiva single port had vent cap were loose closure.The following information was provided by the initial reporter: ¿ i collected a handful of products from the customer where the vent cap is present, but loose in the packaging.¿ d.3.Medical device manufacturer: becton dickinson, franklin lakes, nj was changed to becton dickinson infusion therapy systems inc, sandy, utah.G.1.Manufacturing location: becton dickinson, franklin lakes, nj was changed to becton dickinson infusion therapy systems inc, sandy, utah.D.1.Medical device brand name: bd¿ nexiva single port, d.4.Common device name: intervascular catheter, d.4.Medical device catalog # 383517, d.4.Medical device lot # 8354797, d.4.Serial #: (b)(4), d.4.Medical device expiration date: 2021-11-30, d.4.Unique identifier (udi) #: (b)(4), g.5.Pma / 510(k)#: k161777, h.4.Device manufacture date: 2018-12-20.
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