MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT 18GA 1.75IN (1.3 MM X 45 MM); INTERVASCULAR CATHETER

Catalog Number	383520
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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 has been reported that the bd nexiva single port 18ga 1.75in (1.3 mm x 45 mm) has been found experiencing leakage during use.The following has been provided by the initial reporter: after taking the needle out, the access was leaking and blood came out.
Additional Manufacturer Narrative
Investigation: bd received an 18 gauge nexiva unit from lot 8166590 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no physical/mechanical damage to any of the units.The septum was assembled and seated correctly.Next, a water/air leak test was performed and no leakage was observed coming from the unit.Based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no damage or leakage was observed a definitive root cause could not be determined.
Event or Problem Description
It has been reported that the bd nexiva single port 18ga 1.75in (1.3 mm x 45 mm) has been found experiencing leakage during use.The following has been provided by the initial reporter: after taking the needle out, the access was leaking and blood came out.

• Brand Name: BD NEXIVA SINGLE PORT 18GA 1.75IN (1.3 MM X 45 MM)
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8873987
• Report Number: 1710034-2019-00866
• Device Sequence Number: 2447754
• Product Code: FOZ
• UDI-Device Identifier: 30382903835202
• UDI-Public: 30382903835202
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 383520
• Device Lot Number: 8166590
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other