MAUDE Adverse Event Report: EXELINT INTERNATIONAL, CO. EXEL IV SET 15 DRP/ML,W/Y SITE,VENT/NON-VENT,78" TUBE, LL; IV ADMINISTRATION SET

Catalog Number	29082
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
1.Was the nonconformance detected before or after use? during.2.Was the device used as intended?yes.2.A.If yes, was the device in contact with patient?yes.2.B.If yes, was there an adverse event associated to the use of the device? yes, patient started bleeding.2.C.Was another device used alongside/connected to carry out the procedure? yes.2.D.If yes, please describe the use.Please provide as much detail as possible, i.E.Device used with what solution or media, unusual we used another iv connector amount of force used, unusual positioning, or irregular patient anatomy.3.Was another device used to successfully complete the medical procedure?yes.3.A.If yes, was the other device used successfully from the same lot as nonconforming device?yes.4.Number of devices with the same nonconformance? one was used.5.Date of occurrence: (b)(6) 2024.6.Will nonconforming device be returned? no.(b)(4).
Event or Problem Description
A complaint was received on iv set 15 drp/ml 78" 1y, it was noted in the report that there was a leak in the injector port.The port was never pierced and caused a lot of bleeding.
Additional Manufacturer Narrative
All records were reviewed (production records, product testing and release inspections); raw materials: all raw materials used were tested, qualified for use or approved, and within their expiry dates at the time of use.Personnel: all personnel involved in manufacturing the product were trained and qualified to perform operations as specified in the production record.Calculations: all calculations in the manufacturing process were accurate and correct.Equipment: all equipment used was checked or calibrated.Procedures: all procedures within the production record were followed, and all entries were completed.All reviewed records were found to be in compliance with the quality standards established for this product.There were no abnormalities or non-conformances were noted.The oem has conducted an inspection and test on retained samples, with the following results: all inspected samples passed the visual inspection and were in good appearance.The dosing port were firmly bonded.A clinical suction use test was performed on all samples, and all passed with no leaks detected.In conclusion, all retain samples tested; were found to be qualified for release.No leaks or similar issues were found.Possible causes may include insufficient adhesive during binding to the y-connector or inadequate compression to the y-connectors, although such issues are typically detected during the leak detection test.The likelihood of this occurring is extremely low.The oem has taken proactive measures to train relevant personnel with: applying sufficient amount of adhesive to the product.Conducting timely inspection immediately after assembly to prevent distribution of defective product.No similar complaints to this lot was found.(b)(4).

• Brand Name: EXEL IV SET 15 DRP/ML,W/Y SITE,VENT/NON-VENT,78" TUBE, LL
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach CA 90278
• Manufacturer (Section G): EXELINT INTERNATIONAL, CO.; 2500 santa fe avenue; redondo beach CA 90278
• Manufacturer Contact: vu doan ; 2500 santa fe avenue; redondo beach, CA 90278 ; 3106490707
• MDR Report Key: 19534241
• Report Number: 1035907-2024-00024
• Device Sequence Number: 17696287
• Product Code: FPA
• UDI-Device Identifier: 00020221290820
• UDI-Public: (01)00020221290820(17)280910(30)01(10)231010
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K010404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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?: Yes
• Device Catalogue Number: 29082
• Device Lot Number: 231010
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown