Catalog Number 328440 |
Device Problems
Complete Blockage (1094); Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that 3 bd insulin syringes with bd ultra-fine¿ needles had damaged product and operational issues.The following information was provided by the initial reporter : the consumer reported 3 syringes with multiple issues of broken syringe, hub, barrel and plunger rod, not able to draw up insulin, a pin sized hole in the barrel and insulin sprayed out the hole.Date of event : unknown, sample status : awaiting sample.
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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.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: d9: device available for eval yes.D9: returned to manufacturer on: 01-mar-2022.H6: investigation summary: customer returned a single 0.3ml syringe with no other identification.The syringe appeared undamaged.Functional testing was performed on the syringe.The syringe was capable of drawing, holding, and expelling the water.The syringe was returned undamaged and functioned as intended.A review of the device history record was completed for batch # 1228476 all inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200977255, 200977243] noted that did not pertain to the complaint.There was one (1) notification [200977258] noted for cracked barrel.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of the barrel being broken damaged.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of hub damage.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of the syringe not drawing.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of a hole in the barrel.Based on the sample received, bd was unable to confirm the customer¿s indicated failure of leakage.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
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Event Description
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It was reported that 3 bd insulin syringes with bd ultra-fine¿ needles had damaged product and operational issues.The following information was provided by the initial reporter : the consumer reported 3 syringes with multiple issues of broken syringe, hub, barrel and plunger rod, not able to draw up insulin, a pin sized hole in the barrel and insulin sprayed out the hole.Date of event : unknown.Sample status : awaiting sample.
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Search Alerts/Recalls
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