Catalog Number 320478 |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problems
Pain (1994); Swelling (2091); Skin Tears (2516)
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Event Date 05/31/2019 |
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.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 tearing of the skin occurred during use with a pen needle 32x4 la 5b.The following information was provided by the initial reporter, "the problem is that the tips were not sharp, which causes pain, tearing of the skin, bad penetration and blistering of the skin.".
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Event Description
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It was reported that tearing of the skin occurred during use with a pen needle 32x4 la 5b.The following information was provided by the initial reporter, "the problem is that the tips were not sharp, which causes pain, tearing of the skin, bad penetration and blistering of the skin.".
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Manufacturer Narrative
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Investigation summary: customer returned photos of the shelf carton of 4mm, 32g pen needles from lot # 8045594.Customer states that the tips were not sharp, which causes pain, tearing of the skin, bad penetration and blistering of the skin.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Based on the samples and/or photo(s) received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as the photos do not show the pen needles in question.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no capa is required at this time.
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Search Alerts/Recalls
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