Catalog Number 393232 |
Device Problem
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 11/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 venflon pro 22ga 0.9mm od 25mm experienced needle rust.The following information was provided by the initial reporter: during the insertion, nurse saw rust in the stylet.She immediately removed the entire cannula from the vein.
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Event Description
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It was reported that the bd venflon pro 22ga 0.9mm od 25mm experienced needle rust.The following information was provided by the initial reporter: during the insertion, nurse saw rust in the stylet.She immediately removed the entire cannula from the vein.
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Manufacturer Narrative
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Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).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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Manufacturer Narrative
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H.6.Investigation: the photo was received by bd for evaluation.A quality engineer was able to review the photo of a blister pack for a bd 1ml from lot # 0279502 regarding item # 393232 with the reported issue that ¿during the insertion, nurse saw rust in the stylet.Immediately she removed the entire cannula out from the vein.During this process, tip of the catheter was damaged outside the vein¿.The dhr of material number 393232 and lot number 0279502 was checked and no quality notifications were recorded on this lot.No samples and one photograph were received from the customer and were used for investigation of the reported defects.The investigation team also used retention samples of material code 393232 and lot number 0279502 for investigating the reported defect of rust or dust.None of the ten retention samples showed any rust or dust in them.The received photograph was investigated for the reported defect of presence rust or dust on the stylet.The photograph could not help in investigation and confirm the reported defect.The defect is not confirmed.To confirm the defect and investigate the root cause of the reported defect, the original sample will be required.
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Event Description
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It was reported that the bd venflon pro 22ga 0.9mm od 25mm experienced needle rust.The following information was provided by the initial reporter: during the insertion, nurse saw rust in the stylet.She immediately removed the entire cannula from the vein.
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Search Alerts/Recalls
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