MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ DUAL PORT MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR CATHETER

Model Number	383576
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system ¿ dual port maxzero needleless connector the tubing expanded.There was no report of patient impact.The following information was provided by the initial reporter: during ct scan and contrast administration, iv tubing attached to nexiva herniated out, but did not rupture.Iv was removed and restarted.
Additional Manufacturer Narrative
Patient¿s birthday was not provided, (b)(6) 1984 was used based on age of patient.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd nexiva¿ closed iv catheter system ¿ dual port maxzero needleless connector the tubing expanded.There was no report of patient impact.The following information was provided by the initial reporter: during ct scan and contrast administration, iv tubing attached to nexiva herniated out, but did not rupture.Iv was removed and restarted.
Additional Manufacturer Narrative
H6: investigation summary: it was reported the tubing herniated but did not rupture.As a sample was not returned, a thorough sample investigation could not be completed.A device history record review was completed for provided material number 383576, lot 2286065.The review revealed there were no internal rejects related to the reported issue by the customer.According to the quality records all the inspections of the sampling plan met the acceptance criteria.Additional device histories were reviewed for each batch of needle adapter assemblies used in the manufacturing of this batch and no related quality issues or process deviations were found.Based on the investigation, bd was not able to confirm the defect or associate the incidence with the manufacturing process.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ DUAL PORT MAXZERO NEEDLELESS CONNECTOR
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; periferico luis donaldo; colosio no. 579; nogales ; MX ; 8015652341
• MDR Report Key: 16915984
• Report Number: 9610847-2023-00108
• Device Sequence Number: 2252407
• Product Code: FOZ
• UDI-Device Identifier: 00382903835768
• UDI-Public: (01)00382903835768
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2025
• Device Model Number: 383576
• Device Catalogue Number: 383576
• Device Lot Number: 2286065
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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
• Patient Age: 39 YR
• Patient Sex: Male