Catalog Number UNKNOWN |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date : unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device manufacture date : unknown.
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Event Description
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It was reported that 2 unspecified bd¿ syringe had product damage issues.The following information was provided by the initial reporter : the consumer reported that the plunger snapped in half when taking the injection and needle shields are difficult to remove.Date of event : (b)(6) 2021.Samples : yes.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/10/2021.H.6.Investigation: customer returned (1) loose 0.5ml bd insulin syringe.The customer reported that the plunger snapped in half when taking injection and needle shields are difficult to remove.The returned syringe was examined, and it was observed that the plunger rod was fractured approximately 1¿ from the thumbpress; the plunger rod assembly was fully depressed within the barrel.The returned syringe was examined, then tested to determine the shield removal force and measured within specification at 3.19 lbs (specs: shield removal force for 0.5 ml syringe after sterilization is 0.85 to 5.95lbs).No defects were observed.Due to the batch being unknown, no dhr review can be completed.Root cause for this defect cannot be determined.
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Event Description
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It was reported that 2 unspecified bd¿ syringe had product damage issues.The following information was provided by the initial reporter : the consumer reported that the plunger snapped in half when taking the injection and needle shields are difficult to remove.Date of event : (b)(6) 2021.Samples : yes.
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Search Alerts/Recalls
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