Catalog Number 381812 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/11/2018 |
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.(b)(6).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¿ shielded iv catheter had packaging failure leading to a breach of the sterile barrier.No serious injury or medical intervention was reported.
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Manufacturer Narrative
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Investigation summary: dhr review for lot: 7250624; was previously conducted for investigation (pr 514903-544727) which disclosed the following: a total of (b)(4) units were manufactured on afa line 4 starting on 14sep17 through 18sep17 and packaged on pkg.Line 11 from 15sep17 through 18sep17.All challenge, set up and in process samples were performed per quality control plan and all passed per specifications.No samples or photos were provided for this incident.Relationship of device to the reported incident: indeterminate no units or photos were provided for observation and/or testing of this incident therefore the alleged defect was not identified or confirmed and a root cause was not established.Without the actual sample for evaluation and testing there was no physical/mechanical evidence to confirm or support manufacturing process related issues for the defect stated in the pir.
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Event Description
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It was reported that bd insyte¿ autoguard¿ shielded iv catheter had packaging failure leading to a breach of the sterile barrier.No serious injury or medical intervention was reported.
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Search Alerts/Recalls
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