Catalog Number 301077 |
Device Problems
Detachment Of Device Component (1104); Component Falling (1105); Image Display Error/Artifact (1304); Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/26/2017 |
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.
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Event Description
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It was reported that a bd¿ syringe was found illegible as the syringe numbers were not clear.The plunger rod malfunctioned during use as the plunger fell out as it was pulled.There was no report of injury or medical intervention needed.
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Manufacturer Narrative
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No samples (including photos) were returned for evaluation, however production record review indicates print defects recorded during manufacturing which may be related to those seen by customer.It is not possible to determine without samples or further description.Dhr review for batch 6153870 (p/n 301077): manufacturing dates: 06/22/2016 to 06/24/2016.Batch quantity was (b)(4).All visual inspections were performed as per requirement.A quality notification was issued for smeared print defects during the manufacture of this batch.Production was stopped and printer adjustments were recorded performed.Product was requalified per applicable aql.Batch 6153870 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Conclusion: bd was able to confirm the customer's indicated failure for print defects.Bd was not able to duplicate or confirm the customer's indicated failure for plunger-related defect.Unable to determine a root cause without samples or further description.
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Search Alerts/Recalls
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