Catalog Number 401622 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the bd durasafe plus¿ epidural lock cse needle set was shorter than it was supposed to be.This was noticed prior to use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the epidural needle was shorter than normal".
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Event Description
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It was reported that the bd durasafe plus¿ epidural lock cse needle set was shorter than it was supposed to be.This was noticed prior to use.The following information was provided by the initial reporter, translated from chinese to english: "the epidural needle was shorter than normal".
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Manufacturer Narrative
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H.6.Investigation summary: a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Additionally photographs of the non-conformance were obtained from the facility.Visual analysis of markings found on the surface of the devices found that the two units do not share the same item number designation.This suggests that the issue is not related to a mixing of product lines, most likely occurring as a result of poor line clearance when changing product lines.Bd will continue to track and trend for this issue.H3 other text : see h.10.
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Search Alerts/Recalls
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