Catalog Number 381357 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 an unspecified number of bd insyte-w¿ iv catheter with wings 16ga 1.77in (1.7 x 45 mm) experienced a loose needle which was noted prior to use.The following information was provided by the initial reporter: after removing the protective cover of the needle, the needle starts rotating inside the catheter and does not stop.A safe insertion cannot be guaranteed.The same incident was reported for other products of the same lot, but they are not available.The problem was detected before use.
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Manufacturer Narrative
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Investigation summary: one sample was received by our quality team for evaluation.Upon visual inspection it was observed that the needle hub was damaged which may have caused the catheter to rotate; therefore, the incident can be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Conclusion: based on the investigation the probable root cause could have been that the hub was damaged during manufacturing when the hub was picked up and placed by a gripper.The production technicians were informed of the issue and the gripper had additional maintenance done.
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Event Description
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It was reported that an unspecified number of bd insyte-w¿ iv catheter with wings 16ga 1.77in (1.7 x 45 mm) experienced a loose needle which was noted prior to use.The following information was provided by the initial reporter: after removing the protective cover of the needle, the needle starts rotating inside the catheter and does not stop.A safe insertion cannot be guaranteed.The same incident was reported for other products of the same lot, but they are not available.The problem was detected before use.
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Search Alerts/Recalls
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