Model Number 328440 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that 94 bd insulin syringes with bd ultra-fine¿ needle experienced scale marking issue.The following information was provided by the initial reporter: the customer notices that when pushing the plunger to the bottom of syringe, the seal align to '0' is not accurate.Some of them above '0', some of them in the middle of '0', and some of them below '0'.Please refer to the pictures.She is worried that the injection volume will be affect, so she will check the syringe before using.Currently, she only uses the syringe which seal align below '0'.
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Manufacturer Narrative
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E1.Initial reporter addr 1: (b)(6).H3.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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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: 09-jun-2023.H6: investigation summary: customer returned one shelf carton from lot# 1333189 with (3) 0.3ml x 31g x 8mm syringes in a clear ziploc and (90) 0.3ml x 31g x 8mm syringes in 6 open polybags.The returned syringes were visually examined and observed no issues.The (30) syringes were inspected via gauge to ensure correct placement of the graduation markings and observed the return samples found to be within permitted specifications.Hence, the reported issue could not be confirmed based on the samples return for investigation.The root cause could not be determined because the issue could not be confirmed.A review of the device history record was completed for batch# 1333189.All inspections and challenges were performed per the applicable operations qc specifications.H3 other text : see h10.
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Event Description
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It was reported that 94 bd insulin syringes with bd ultra-fine¿ needle experienced scale marking issue.The following information was provided by the initial reporter: the customer notices that when pushing the plunger to the bottom of syringe, the seal align to '0' is not accurate.Some of them above '0', some of them in the middle of '0', and some of them below '0'.Please refer to the pictures.She is worried that the injection volume will be affect, so she will check the syringe before using.Currently, she only uses the syringe which seal align below '0'.
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Search Alerts/Recalls
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