Model Number 320109 |
Device Problem
Misconnection (1399)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2022 |
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.Initial reporter name and address: initial reporter e-mail: unknown.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 the bd ultra fine¿ pen needle was difficult to attach to the pen.The following information was provided by the initial reporter: "she is having difficulty holding it while trying to attach it to the pen.She stated that it falls on the floor before she can attach it.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 30-sep-2022.H6: investigation summary: customer returned (3) unopened 31gx8mm bd pen needles from lot# 1342161.The customer reported that the needle hub is smaller than usual, and is having difficulty holding it while trying to attach to a pen.The samples were examined, then tested for attachment to a test pen injector.All 3 pen needles were able to be threaded onto and off the pen injector properly.No evidence of manufacturing defect that could cause difficulty with attachment or with the dimension of the hub was observed.The alleged issues could not be confirmed based on the samples returned for investigation.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 as per the applicable operations and met qc specifications.Embecta was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.
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Event Description
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It was reported that the bd ultra fine¿ pen needle was difficult to attach to the pen.The following information was provided by the initial reporter: "she is having difficulty holding it while trying to attach it to the pen.She stated that it falls on the floor before she can attach it.".
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Search Alerts/Recalls
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