Catalog Number NOD10LPT |
Device Problems
Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of gfay2554 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported that the package was broken before it was delivered, therefore the product wasn't delivered to the hospital.Update 12/18/17 - additional information reported by the facility that the circle shows the package was not sealed and not sterile apparently after they opened the outer box.Update 03/14/2018- sample evaluation found evidence that the bottom end of the packaging was improperly sealed.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of an unsealed package is confirmed to be manufacturing related.One 10 f navarre opti-drain drainage catheter was returned for investigation.The packaging appears to be open from the bottom side.The open end of the packaging was returned folded and taped to the back.The tape was removed to observe the open end of the packaging.No signs of adhesion between the transparent plastic and the tyvek were observed on the open end of the packaging.The top side of the packaging was partially opened to compare the adhesive residue to the open end on the bottom side.The sample will be forwarded to the manufacturing facility for further evaluation.A lot history review (lhr) of gfay2554 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported that the package was broken before it was delivered, therefore the product wasn't delivered to the hospital.12/18/2017 - additional information reported by the facility that the circle shows the package was not sealed and not sterile apparently after they opened the outer box.03/14/2018- sample evaluation found evidence that the bottom end of the packaging was improperly sealed.
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Search Alerts/Recalls
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