MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT; PERIPHERAL IV CATHETER

Catalog Number	383518
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of foreign matter on the catheter was confirmed; however, the source and composition of the material could not be determined from the photograph that was provided for investigation.The photo showed the nexiva catheter in an open package without the needle cover.A brown colored material appeared to be touching the external surface of the catheter.As the device was not sealed within the packaging and without the physical sample provided for analysis, the source and composition of the material could not be determined.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.
Event or Problem Description
It was reported that bd nexiva single port foreign matter found on cannula.The following information was provided by the initial reporter, translated from german to english: before use when opening the packaging, the user found soiling in the packaging and on the cannula.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of foreign matter on the catheter was confirmed; however, the source and composition of the material could not be determined from the photograph that was provided for investigation.The photo showed the nexiva catheter in an open package without the needle cover.A brown colored material appeared to be touching the external surface of the catheter.As the device was not sealed within the packaging and without the physical sample provided for analysis, the source and composition of the material could not be determined.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: BD NEXIVA SINGLE PORT
• Common Device Name: PERIPHERAL IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20072276
• Report Number: 1710034-2024-00938
• Device Sequence Number: 6507698
• Product Code: FOZ
• UDI-Device Identifier: 00382903835188
• UDI-Public: (01)00382903835188
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: Health Professional
• Device Catalogue Number: 383518
• Device Lot Number: 4029683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown