Catalog Number 383712 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2021 |
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.(b)(4).
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Event Description
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It was reported that 10 bd pegasus¿ safety closed iv catheter systems experienced catheter damage/deformation and damaged or open unit seals/packaging where sterility was compromised.The following information was provided by the initial reporter: the teacher of the department opened the package and found that some indwelling needles were damaged, and some needles were exposed.At the same time, he found a box of needles with the same problem, which could not be used clinically.
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Event Description
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It was reported that 10 bd pegasus¿ safety closed iv catheter systems experienced catheter damage/deformation and damaged or open unit seals/packaging where sterility was compromised.The following information was provided by the initial reporter: the teacher of the department opened the package and found that some indwelling needles were damaged, and some needles were exposed.At the same time, he found a box of needles with the same problem, which could not be used clinically.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-02-22 h6: investigation summary a device history review was conducted for lot number 0055977.Our records show that this is the only instance of a 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.Additionally, the sample submitted by the facility has been reviewed by our team of quality engineers.They noted that the breach in each package occurred at different locations and were not consistent.After conducting a thorough review of the manufacturing process our engineers were not able to identify a root cause that would associate this issue with the manufacturing or packaging processes.H3 other text : see h10.
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Search Alerts/Recalls
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