Catalog Number 302130 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2021 |
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 when using the bd syringe 5ml ls, the device experienced discolored blister pack/ primary packaging.The following information was provided by the initial reporter.The customer stated: there is a foreign body in the package.
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Manufacturer Narrative
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H.6.Investigation: one photo was received by our quality team for evaluation.From the photos, foreign matter was observed inside the syringe packaging and products.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.As no samples were returned to determine the foreign matter type, the root cause could not be determined.
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Event Description
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It was reported when using the bd syringe 5ml ls, the device experienced discolored blister pack/ primary packaging.The following information was provided by the initial reporter.The customer stated: there is a foreign body in the package.
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Manufacturer Narrative
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The following fields were updated due to additional information:
d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/8/2021.H.6.Investigation: one photo was received by our quality team for evaluation.From the photos, foreign matter was observed on the barrel flange.From the returned sample, brown foreign matter was observed on the barrel syringe.The brown foreign matter was sent for fourier transform infrared spectroscopy (ftir) analysis to determine the foreign matter type.The ftir results show that the spectrum of the foreign matter had no good match available in the library.The foreign matter showed some peaks that were similar to that of polypropylene, likely the base material of the syringe.This was likely because some of the base material was embedded in the foreign matter.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the device history record review, there is no heater change on the mold / press and no abnormality during the production run for the affected syringe batches.There were also no similar complaints received on embedded foreign matter associated with the syringe batches.Based on available information that only one piece of syringe is affected, the likely probable cause could have been attributed to contaminants in the resin where during the injection molding process the contaminants became embedded to the syringe barrel.
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Event Description
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It was reported when using the bd syringe 5ml ls, the device experienced discolored blister pack/ primary packaging.The following information was provided by the initial reporter.The customer stated: there is a foreign body in the package.
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Search Alerts/Recalls
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