Catalog Number 38182314 |
Device Problems
Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Information (3190)
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Event Date 03/25/2019 |
Event Type
malfunction
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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.Initial reporter phone#: (b)(6).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 that the bd insyte¿ autoguard¿ shielded iv catheter had "dirt" inside the sealed packaging before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "peripheral intravenous catheter with safety device 22g, lot 8298682, with presence of dirt in the catheter inside the sealed package.".
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Manufacturer Narrative
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Investigation: dhr review: this lot was reviewed regarding the tests of ¿foreign matter¿ and were not evidenced records for this claimed defect.It was received one sample of insyte autoguard 22g at bd juiz de fora, on (b)(6) 2019, lot: 8298682 in original and open package.The sample was visually analyzed and it was verified that the foreign matter on the outside of the shield, since the shield is a molded component in sandy from bulk comes to juiz de fora assembly line.Based on the results of the investigation to date a root cause has not been determined for the defect described in this complaint since the protector is a component molded in sandy from comes bulk to assembly line from juiz de fora.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had "dirt" inside the sealed packaging before use.The following information was provided by the initial reporter, translated from portuguese to english: "peripheral intravenous catheter with safety device 22g, lot 8298682, with presence of dirt in the catheter inside the sealed package.".
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Search Alerts/Recalls
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