Model Number 328291 |
Device Problems
Leak/Splash (1354); Defective Device (2588)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported while using bd ultra-fine¿ insulin syringes short needle 31g 3/10cc 5/16in when removing shield the hub separated from device.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that needle hub separated and shields were difficult to remove.
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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: 2021-02-09.H6: investigation summary: customer returned (1) loose 3/10cc syringe.Customer states that the needle hub separated and the shields were difficult to remove.The returned syringe was examined and exhibited the hub-needle/shield assembly separated from the barrel.A review of the device history record was completed for batch # 9161979 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause for this defect cannot be determined.Capa1630423 has been opened to address this issue.H3 other text : see h10.
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Event Description
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It was reported while using bd ultra-fine¿ insulin syringes short needle 31g 3/10cc 5/16in when removing shield the hub separated from device.There was no reported patient impact.The following information was provided by the initial reporter: it was reported that needle hub separated and shields were difficult to remove.
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Search Alerts/Recalls
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