Catalog Number 990173 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/12/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.(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 before us it was noticed that bd plastipak¿ syringes had plastic burrs in the syringe.
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Event Description
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It was reported that before use, seven bd plastipak¿ syringes had plastic burrs in the syringe.
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Manufacturer Narrative
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Correction: describe event or problem: it was reported that before use, seven bd plastipak¿ syringes had plastic burrs in the syringe.Investigation summary: device history record, quality notification and maintenance records were analyzed and no occurrences potentially related to the defect was observed.Investigation conclusion: the samples sent by the customer were verified and it was possible observe foreign matter ¿ plastic residue.According to the bd foreign matter evaluation procedure, the fm were identified.One sample at level 1, two samples at level 2 and four samples at level 3 in size ranking.Root cause description: the potential root cause for the foreign matter incident is associated with the assembly process.Rationale: the incident identified from this complaint will be monitored for trend evaluation.
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Search Alerts/Recalls
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