Catalog Number 328438 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd insulin syringe with bd ultra-fine¿ needle had mixed product in packaging.No serious injury or medical intervention was reported.
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Manufacturer Narrative
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Investigation summary: customer returned (2) loose 3/10cc syringes with no packaging.Customer states that they found two different size needles on her syringes.Both returned syringes were tested using the length gauge and one sample fell within specifications for 8mm cannula length.The remaining sample fell within specifications for 12.7mm cannula length.A review of the device history record was completed for batch # 7240810 all inspections were performed per the applicable operations qc specifications.There were five (5) notifications [200719340, 200719497, 200719065, 200711711, 200711496] noted that did not pertain to the complaint.Investigation conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no packaging was returned with the samples to determine which batch the samples came from.
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Event Description
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It was reported that bd insulin syringe with bd ultra-fine¿ needle had mixed product in packaging.No serious injury or medical intervention was reported.
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Search Alerts/Recalls
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