MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Catalog Number	383322
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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 3rd 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: (17-aug-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".
Additional Manufacturer Narrative
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.
Event or Problem Description
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 3rd 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: (17-aug-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.".

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17628038
• Report Number: 3014704491-2023-00484
• Device Sequence Number: 7545049
• Product Code: FOZ
• UDI-Device Identifier: 00382903833221
• UDI-Public: 00382903833221
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K923702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 383322
• Device Lot Number: 2259638
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown