Catalog Number 391592 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Discomfort (2330)
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Event Date 09/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing location for this product is bawal.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd venflon iv cannula 20g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: while using venflon i 20g , the staff reported of leakage in the catheter material.This lead to pain to the patient and nursing staff too was taken aback as to how could this happen.The device and packaging was discarded but issue was reported to us.
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Event Description
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It was reported while using bd venflon iv cannula 20g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: while using venflon i 20g , the staff reported of leakage in the catheter material.This lead to pain to the patient and nursing staff too was taken aback as to how could this happen.The device and packaging was discarded but issue was reported to us.
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Manufacturer Narrative
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A video was received by bd for evaluation.A quality engineer was able to review the video of a venflon i 20g with an unknown lot number regarding material number 391592 for the reported defect of ¿leakage at catheter junction¿.Based on the video defect is difficult to confirm.The device history review was not completed due to the lot number being unknown.Investigation and simulation were not carried out on retention samples due to the lot number being unknown.The exact root cause can only be determined if we receive the original sample and lot number.H3 other text : see h10.
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Search Alerts/Recalls
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