BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER, WITH BD VIALON¿ CATHETER; INTRAVENOUS CATHETER
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Catalog Number 382654 |
Device Problem
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 07/31/2018 |
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 #: 6048707, expiration date: 2019-02-28, manufacture date: 2016-02-17.Medical device lot #: 5300879, expiration date: 2018-11-30, manufacture date: 2015-10-28.Medical device lot #: 7118676, expiration date: 2020-04-30, manufacture date: 2017-04-28.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¿ autoguard¿ bc shielded iv catheter, with bd vialon¿ catheter had sterile breach due to packaging being slightly open.There was no report of exposure, serious injury or medical intervention.
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Event Description
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It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter, with bd vialon¿ catheter had sterile breach due to packaging being slightly open.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 manufacture: yes.Investigation summary: a review of the device history record revealed no irregularities during the manufacture of the reported lot.Some returned packages were partially opened, but this is the basis of the complaint.Received a total of 96 units.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 vaiables that affect seal quality are seal transfer/width and top web adhesive presence.Both of these variables were included in the investigation.Conclusions: 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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