Catalog Number 301948 |
Device Problem
Fungus in Device Environment (2316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2021 |
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.
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Event Description
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It was reported that 2 bd¿ 20 ml syringe with needles experienced mold presence.The following information was provided by the initial reporter: syringe-there is a black spot in the syringe.The black spot is at the part where the needle and the barrel are connected.The customer thinks that it is mold.The department where the problem occurred is nephrology.
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Manufacturer Narrative
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H6: investigation summary: a device history record review was completed for provided lot number 2006103.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, two picture samples were returned for evaluation by our quality engineer team.Through examination of the pictures, foreign matter was observed within the blister packaging.The foreign matter was identified as a piece of dirty packaging film.The packaging for this product consists of both film and paper webbing which are sealed through pressure and temperature.Metal clips are used to move the blister packaging through the manufacturing process.It has been determined that a small piece of the packaging broke and remained within the metal clip.The piece of packaging was then recirculated through the process and ended up within another blister package.Despite the fact that the high volume manufacturing process may generate some particulate matter, bd employs highly capable processes to keep particulate matter to extremely low levels.Stringent manufacturing processes and environmental controls are in place.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.Further action has not been determined necessary at this time.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
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Event Description
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It was reported that 2 bd¿ 20 ml syringe with needles experienced mold presence.The following information was provided by the initial reporter: syringe-there is a black spot in the syringe.The black spot is at the part where the needle and the barrel are connected.The customer thinks that it is mold.The department where the problem occurred is nephrology.
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Search Alerts/Recalls
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