Catalog Number 388638 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: (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 the bd¿ prn adapter experienced device damage while still considered operable.The following information was provided by the initial reporter, translated from chinese: patient reported that there was fluid leakage at the cap of the prn that had been used to seal the tube.After verification, it was found that the prn was defective, which made it impossible to tighten, resulting in fluid leakage.
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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 1137796.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Event Description
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It was reported that the bd¿ prn adapter experienced device damage while still considered operable.The following information was provided by the initial reporter, translated from chinese: patient reported that there was fluid leakage at the cap of the prn that had been used to seal the tube.After verification, it was found that the prn was defective, which made it impossible to tighten, resulting in fluid leakage.
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Search Alerts/Recalls
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