Catalog Number 383322 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Extravasation (1842)
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Event Date 08/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 extravasation occurred with the bd saf-t-intima¿ iv catheter safety system during use, causing swelling at the injection site.No further information was provided.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "customer has received defective product that didn't work with the patient & give the results as it should.They compared it with another lot number they had & it worked for the patients & gave the correct results.They have only opened 1 bx, 6 ea left, and 3 bx are in the original packaging & unopened.Additional info from customer: (b)(6) 2023 -can you describe more on the defects found on the product? multiple iv¿s infiltrated with this catheter lot # and have been very few previously.Iv¿s were done with other product, and exam completed without infiltration.-is there any adverse event or serious injury happened? patients had swollen injection sites as it does with infiltration, and patient complaints.1.-what is the occurrence number? to my knowledge, no visible defect in the catheter itself as far as the materials/appearance 2.While using the catheters from that lot number, 3 of our patients had an iv extravagate in one weeks¿ time, two different nurses using same product with same lot number 3.3 patients, 3 catheters within 5 days 4.Unsure of specific dates".
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Event Description
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It was reported that extravasation occurred with the bd saf-t-intima¿ iv catheter safety system during use, causing swelling at the injection site.No further information was provided.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "customer has received defective product that didn't work with the patient & give the results as it should.They compared it with another lot number they had & it worked for the patients & gave the correct results.They have only opened 1 bx, 6 ea left, and 3 bx are in the original packaging & unopened.Additional info from customer: on (b)(6) 2023).Can you describe more on the defects found on the product? multiple iv¿s infiltrated with this catheter lot# and have been very few previously.Iv¿s were done with other product, and exam completed without infiltration.Is there any adverse event or serious injury happened? patients had swollen injection sites as it does with infiltration, and patient complaints.1.What is the occurrence number? to my knowledge, no visible defect in the catheter itself as far as the materials/appearance.2.While using the catheters from that lot number, 3 of our patients had an iv extravagant in one weeks¿ time, two different nurses using same product with same lot number.3.3 patients, 3 catheters within 5 days.4.Unsure of specific dates.".
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Manufacturer Narrative
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H.6.Investigation summary: a device history review was conducted for lot number: 2259638.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was 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.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Search Alerts/Recalls
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