Catalog Number 306574 |
Device Problems
Air Leak (1008); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/25/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The reported lot # does not exist for the reported cat #.Therefore, the device manufacture and expiration dates are unknown.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.No samples or photos were received in the columbus plant for evaluation.This is the first complaint for lot# 7076670 for the same defect or symptom.There was no documentation of the issue identified in the complaint during this production run for batch 7076670.There were no qns issued during the production of this batch listed in the complaint.All inspections were accepted during the production of this batch.There were no voids/ bubbles on molded parts and missing barrel label issues documented.No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.The investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.
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Event Description
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"it was reported before use of the 5 ml bd posiflush¿ sp it was noted that one contained a large air bubble and the other had no labeling on it¿ there was no report of injury or medical intervention.
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Manufacturer Narrative
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Bd received a sample from the customer facility for investigation.The sample was evaluated and the customer's indicated failure mode for missing label with the incident lot was observed.There were no voids/ bubbles on molded parts.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: an absolute root cause for this incident cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.
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Search Alerts/Recalls
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