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

Model Number	383510
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported lot # [9357495] was not found for the reported catalog # [383510].Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the bd nexiva¿ single port catheter was defective during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "it is impossible to purge them before pricking the vein and for others, it is impossible to pierce the skin to mount the catheter in the vein.Patient pricked several times.".
Event or Problem Description
It was reported that the bd nexiva¿ single port catheter was defective during use.The following information was provided by the initial reporter, translated from french to english: "it is impossible to purge them before pricking the vein and for others, it is impossible to pierce the skin to mount the catheter in the vein.Patient pricked several times.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD NEXIVA SINGLE PORT CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10759727
• Report Number: 1710034-2020-00701
• Device Sequence Number: 4111849
• Product Code: FOZ
• UDI-Device Identifier: 30382903835103
• UDI-Public: 30382903835103
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 383510
• Device Catalogue Number: 383510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1