Catalog Number 4290 |
Device Problems
Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Air/Gas in Device (4062)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Other text: b3: date of event is unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the needle was too loose on the safety system, which meant that air enters the syringe when it is drawn up and that fluid leaks next to the needle when injecting.The needle spontaneously comes loose from the safety system during the puncture.Adverse patient effects are unknown.It was reported that no further information is available.
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Manufacturer Narrative
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Evaluation codes: updated.No product was returned.The customer provided two photos, one identifying the lot number and the second showing the product configuration.Visual inspection of the pictures did not reveal any defects or anomalies.Without a product sample the reported problem for difficulties with the hypodermic could not be verified and/or confirmed with confidence; therefore, no further action will be conducted at this time.It is possible that the issues observed by the customer may have occurred if the mating luers of the components were not seated as instructed within the instructions for use (ifu).It is suggested to use a twisting motion when attaching the syringe to the luer connection of the needle-pro device.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.The issue will be monitored for threshold or escalation.If the product is returned the manufacturer will re-open the complaint for further device analysis.
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Search Alerts/Recalls
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