Catalog Number 324892 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Inflammation (1932)
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Event Date 08/01/2019 |
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.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 5047782.Medical device expiration date: 04/30/2020.Device manufacture date: 02/16/2015.Medical device lot #: 5348743, medical device expiration date: 02/28/2021.Device manufacture date: 12/14/2015.Medical device lot #: 6172646, medical device expiration date: 08/31/2021, device manufacture date: 06/20/2016.
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Event Description
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It has been reported that the syringe 0.5ml 29ga 12.7mm blister 200bx has been found experiencing patient-device incompatibility during use.The following has been provided by the initial reporter: inflammatory reaction after administration of a drug with one of the lots mentioned.
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Manufacturer Narrative
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Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 5348743.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch# 6172646.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted that did not pertain to the complaint.A review of the device history record was completed for batch# 5047782.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted that did not pertain to the complaint.
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Event Description
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It has been reported that the syringe 0.5ml 29ga 12.7mm blister 200bx has been found experiencing patient-device incompatibility during use.The following has been provided by the initial reporter: inflammatory reaction after administration of a drug with one of the lots mentioned.
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Search Alerts/Recalls
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