Catalog Number 381511 |
Device Problems
Problem with Sterilization (1596); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7062566; medical device expiration date: 2020-02-29; device manufacture date: 2017-03-07.Medical device lot #: 7293637; medical device expiration date: 2020-09-30; device manufacture date: 2017-10-23.Medical device lot #: 6056539; medical device expiration date: 2019-02-28 device manufacture date: 2016-02-25.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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Event Description
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It was reported that bd insyte-n¿ autoguard¿ shielded iv catheters have sterile breach due to a slightly opened packages.There was no report of exposure, serious injury or medical intervention.
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Manufacturer Narrative
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Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: yes.Investigation summary: dhr-review of dhr revealed all required challenge samples and testing was conducted per specifications and in accordance with the in-process sampling plans.No quality notification were initiated during the build of this lot number.Received 30 unused iag 24ga units in partially opened packages.Packages were partially opened at both ends.All units: the product characteristics require a minimum of 1/8¿ seal width with adhesive transfer from the top web paper to the bottom web film.This characteristic was met.The key variables that affect seal strength are seal transfer/width and top web glue.Both of these variables were included in the investigation.Water-leak test: the water leak test was performed on the packages where the seal had not been compromised.No leakage was observed on any of the areas of the packages tested.Conclusion(s): supplier oliver-tolas (ot) uses a standard reinforced paper that is common to many other suppliers, but the adhesive type and application is specific to ot.There is sufficient evidence to demonstrate the ot material or adhesive application is the root cause.
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Event Description
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It was reported that bd insyte-n¿ autoguard¿ shielded iv catheters have sterile breach due to a slightly opened packages.There was no report of exposure, serious injury or medical intervention.
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Search Alerts/Recalls
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