Catalog Number 383328 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cellulitis (1768)
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Event Date 10/28/2019 |
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 #: 8290668; medical device expiration date: 2022-09-30; device manufacture date: 2018-11-30.Medical device lot #: 8334770; medical device expiration date: 2022-11-30; device manufacture date: 2019-01-03.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 saf-t-intima¿ iv catheter safety system was used and the customer had an infection.This was discovered during use.The following information was provided by the initial reporter: cellulite infection after using sc saf-t-intima, involving redness, fever, and swelling in the insertion site, in one patient it appears on the same day and in two patients after 3-4 days.The patients needed antibiotics for treating the infection.
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Manufacturer Narrative
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Investigation summary: a device history review was conducted for lot numbers 8290668 & 8334770.Our records show that this is the second instance of this issue occurring in either production batch.According to the sampling plan applied for product performance, these lots were accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.
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Event Description
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It was reported that bd saf-t-intima¿ iv catheter safety system was used and the customer had an infection.This was discovered during use.The following information was provided by the initial reporter: cellulite infection after using sc saf-t-intima, involving redness, fever, and swelling in the insertion site, in one patient it appears on the same day and in two patients after 3-4 days.The patients needed antibiotics for treating the infection.
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Search Alerts/Recalls
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