BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA; Syringe, piston
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Model Number 320440 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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¿the customer has the bd needles in the clinic if they need to be sent in.They have been ordering these for the last 6 years and have never had an issue with them until the last 2 months.They feel this lot number or batch is bad.Their clinic goes through approximately 200 needles a day and this has been going on for 2 months.Following issues: needle sharpness-blunt.Faulty plunger.Plunger bending breaking off.End breaking off or beginning when trying to inject.Weak spots in plunger, overall not safe.Arriving with needle through the cap.Needles bent¿.
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Manufacturer Narrative
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Investigation summary: no physical samples were received however the investigation was performed based on the photo(s) provided.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
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Search Alerts/Recalls
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