Catalog Number 381823 |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with sterile breach.It was stated ¿he packages weren't sealed properly.¿ there was no report of injury or further medical intervention.
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Manufacturer Narrative
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Device returned to manufacture: yes.
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Event Description
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It was reported with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with sterile breach.It was stated ¿he packages weren't sealed properly.¿ there was no report of injury or further medical intervention.
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Event Description
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It was reported with the use of the bd insyte¿ autoguard¿ shielded iv catheter there was an issue with sterile breach.It was stated ¿he packages weren't sealed properly.¿ there was no report of injury or further medical intervention.
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Manufacturer Narrative
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Received five unused iag 22ga units in partially opened packages and three unused representative iag 22ga units in sealed packages from the lot number 7110801.Customer identified the reported defect of open seals and documented the same with photographs.Five of the packages were partially opened at both end of the blister pack.The seals were not compromised in the representative units.The product characteristics require a minimum of 1/8¿ seal transfer.This characteristic was met.In addition, the paper top web of the returned unit was analyzed under uv light.The adhesive used to seal the top and bottom webs together is uv fluorescent.The analysis revealed an adequate transfer (adhesive) from the top web to the bottom web.The key variables that affect the seal are: seal transfer/ width and top web adhesive presence.Both of these variables were looked at during the investigation.The defect package seal integrity poor/questionable was confirmed with the returned units.Even though the packages were partially opened, all the processes characteristics that directly influence the seal were observed to be within specification.Dhr review was performed on the lot number 7110801: the lot number was manufactured on afa line 5 from april 25, 2017 thru april 30, 2017.Packaged on packaging line 11 from april 30, 2017 thru may 2, 2017.Review of the dhr¿s revealed all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.
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Search Alerts/Recalls
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