Catalog Number UNKNOWN |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
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Event Description
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It was reported that while using an unspecified bd¿ pen needle the needle broke.The following information was provided by the initial reporter, translated from portuguese to english: the client informed a broken needle.The person in charge reports that when he changed the ampoule to continue with the patient's application, the medication didn't come out even when the needles were inserted.He said that when he removed the needle to check, he realized that a piece of the needle had got stuck in the rubber of the ampoule.
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Manufacturer Narrative
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H.6.Investigation summary: no samples were returned therefore the investigation was performed based on the photo(s) provided.Embecta was able to confirm the customer-indicated issue.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
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Event Description
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It was reported that while using an unspecified bd¿ pen needle the needle broke.The following information was provided by the initial reporter, translated from portuguese to english: the client informed a broken needle.The person in charge reports that when he changed the ampoule to continue with the patient's application, the medication didn't come out even when the needles were inserted.He said that when he removed the needle to check, he realized that a piece of the needle had got stuck in the rubber of the ampoule.
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Search Alerts/Recalls
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