Catalog Number 301866 |
Device Problems
Unsealed Device Packaging (1444); Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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In this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd discardit ii 2 ml with 25g x 1, the device experienced scale marking issues, damaged unit packaging where sterility is compromised and foreign matter within the fluid path.The following information was provided by the initial reporter.The customer stated: online rejection for marking defects, double needle, black spots and hair, blister leakage.
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Event Description
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It was reported when using the bd discardit ii 2 ml with 25g x 1, the device experienced scale marking issues, damaged unit packaging where sterility is compromised and foreign matter within the fluid path.The following information was provided by the initial reporter.The customer stated: online rejection for marking defects, double neelde, black spots and hair, blister leakage,.
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Manufacturer Narrative
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H.6.Investigation: no samples (including photos) were returned for the reported issue of ¿scale marking issue, foreign matter and package damage¿ with lot number 0214098 regarding item # 301866, so retention samples were used for the investigation.The dhr of material number 301866 with batch number 0214098 was checked and there were no quality notifications found.The investigation and simulation was carried out on ten retention samples where the investigating team has visually tested the samples and no scale marking issue, foreign matter or package damage was found in the ten retention samples.The investigating team could not confirm the reported defect.The root cause cannot be determined as there is no sample or photograph to investigate the defect.H3 other text : see h.10.
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Search Alerts/Recalls
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