Catalog Number UNKNOWN |
Device Problem
Break (1069)
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Patient Problem
Bruise/Contusion (1754)
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Event Date 12/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.The customer's address is unknown: (b)(6) usa has been used as a default. 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.(b)(4).
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Event Description
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It was reported that 3 unspecified bd introsyte¿ introducer experienced sheaths that would not split as intended.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Hematoma.Splittable sheath did not completely separate / introducer did not peel apart correctly.Introducer was used to insert a picc or other device but the device would not advance.
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Manufacturer Narrative
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H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.
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Event Description
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It was reported that 3 unspecified bd introsyte¿ introducer experienced sheaths that would not split as intended.The following information was provided by the initial reporter: material no: unknown; batch no: unknown.Hematoma.Splittable sheath did not completely separate / introducer did not peel apart correctly.Introducer was used to insert a picc or other device but the device would not advance.
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Manufacturer Narrative
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The following field was updated due to correction: h: no.Of events summarized: 3.
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Event Description
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It was reported that 3 unspecified bd introsyte¿ introducer experienced sheaths that would not split as intended.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Hematoma.Splittable sheath did not completely separate / introducer did not peel apart correctly.Introducer was used to insert a picc or other device but the device would not advance.
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Search Alerts/Recalls
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