Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Anaphylactic Shock (1703)
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Event Date 08/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).Medical device expiration date: unknown.The customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the patient experience allergic reactions after using unspecified bd¿ posiflush syringe.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that the patient experienced allergic reactions when using posiflush syringes.Event description per email states: pt asking for the moc for our ns and heparin posiflush syringes.She states that she was using our ns posiflush syringes 2 years ago and was experiencing anaphylactic reactions.She now to needs to have a cvad placed and will need to use the ns and heparin posiflush again and needs to know what they are made of that could be causing this reaction.She also states she is allergic to gadolinium and has a metallic taste and smell when she used the ns flushes.
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Event Description
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It was reported that the patient experience allergic reactions after using unspecified bd¿ posiflush syringe.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that the patient experienced allergic reactions when using posiflush syringes.Event description per email states: pt asking for the moc for our ns and heparin posiflush syringes.She states that she was using our ns posiflush syringes 2 years ago and was experiencing anaphylactic reactions.She now to needs to have a cvad placed and will need to use the ns and heparin posiflush again and needs to know what they are made of that could be causing this reaction.She also states she is allergic to gadolinium and has a metallic taste and smell when she used the ns flushes.
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Manufacturer Narrative
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H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
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Search Alerts/Recalls
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