Catalog Number 381833 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.
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Event Description
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It was reported that bd insyte autoguard has foreign matter inside the cap.The following information was provided by the initial reporter: 1.Please describe the specific issue found on defective product? black specs noted inside the cap of the needle upon opening a new angiocath 2.How was the patient outcome? are there any clinical signs, health consequences or impact? no impact to patient, the product was switched to a new angiocath after careful inspection.3.Any adverse event or serious injury reported to patient or health care professional? no 4.Are you able to provide the dates of the events in the format of mm-dd-yyyy? if unknown, can state unknown.(b)(6) 2023.
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Event Description
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No additional information.
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Manufacturer Narrative
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Investigation results: the complaint of black specs on the device was confirmed and the cause appeared to be manufacturing related.Three photographs of a 20g insyte autoguard unit show black spots on the barrel, which were consistent with burnt resin that become embedded within the molded part.If the foreign matter is embedded in the device, this defect most likely occurred during the molding process.During molding, resin is used to form the device.It¿s possible that previous resin got burnt and was still present when this device was in the molding process, causing the black solid foreign matter.The appropriate manufacturing personnel were notified of this complaint.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion(s): the defect of ¿foreign matter¿ was confirmed.Probable root cause(s): manufacturing/molding.
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Search Alerts/Recalls
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