Model Number M00518351 |
Device Problems
Device Contaminated During Manufacture or Shipping (2969); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).Although expected, the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that an interject needle was received and a hair was found inside the sterile package.There was no patient involvement with this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).Investigation results: an interject needle was received by boston scientific.The device was received in its original, sealed pouch.Visual analysis of the returned device revealed a hair inside the pouch.Additionally, it was observed that the shipping clip detached and the was needle prematurely extended within the package.No other issues were noted.It is most likely that detachment of the shipping clip occurred as result of transport/storage.Handling and manipulation of the device can cause the clip to fall off from handle which can then cause the needle to prematurely extend inside the pouch.Analysis revealed that the hair was found caught on the heat seal area of the pouch.Based on the information available and the analysis performed, the most probable cause of the reported event is manufacturing deficiency, due to problems traced to manufacturing process.There is an investigation to address this issue.
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Event Description
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It was reported to boston scientific corporation that an interject needle was received and a hair was found inside the sterile package.There was no patient involvement with this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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