Catalog Number UNKNOWN |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
No Information (3190)
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Event Date 12/10/2020 |
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.Date of event: unknown.The date received by manufacturer has been used for this field.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.Fda device problem code: (b)(4).Fda patient problem code: (b)(4).
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Event Description
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It was reported that the unspecified bd introsyte¿ introducers splittable sheath separated and broke off in the patient's vein, and did not split as intended.The following information was provided by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced splittable introducer sheath separated and broke off in the patient¿s vein, splittable sheath did not completely separate / introducer did not peel apart correctly and plastic tip of introducer seemed to stick / adhere to the catheter.".
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Manufacturer Narrative
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H6: investigation summary bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
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Event Description
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It was reported that the unspecified bd introsyte¿ introducers splittable sheath separated and broke off in the patient's vein, and did not split as intended.The following information was provided by the initial reporter: "it was reported via introsyte introducer survey that the clinician experienced splittable introducer sheath separated and broke off in the patient¿s vein, splittable sheath did not completely separate / introducer did not peel apart correctly and plastic tip of introducer seemed to stick / adhere to the catheter.".
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Search Alerts/Recalls
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