MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT 24GA 0.56IN (0.7 MM X 14 MM); INTRAVASCULAR CATHETER

Model Number	383510
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that leakage occurred during use with a bd nexiva single port 24ga 0.56in (0.7 mm x 14 mm).The following information was provided by the initial reporter, "i have a 24 gauge nexiva iv catheter that was used on a patient that had a leak between the hub and tubing.".
Additional Manufacturer Narrative
H.6.Investigation summary our quality engineer inspected the sample for evaluation.Bd received one used nexiva 24 g unit with no packaging from material number 383510, lot number unknown.No needle set was returned for evaluation.Through the visual/microscopic evaluation a slit was observed approximately one inch from the nose of the straight adapter.The damage was observed to have rounded damage.A water/air leak test was performed, and air bubbles were observed coming from the area of the slit/cut.The reported issue was confirmed.Damage to the tubing can happen in various locations during manufacturing.The deep round indents in the tubing help narrow down this possibility.A device history record review could not be performed as the lot number was unknown.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that leakage occurred during use with a bd nexiva single port 24ga 0.56in (0.7 mm x 14 mm).The following information was provided by the initial reporter, "i have a 24 gauge nexiva iv catheter that was used on a patient that had a leak between the hub and tubing.".

• Brand Name: BD NEXIVA SINGLE PORT 24GA 0.56IN (0.7 MM X 14 MM)
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9597284
• Report Number: 1710034-2020-00010
• Device Sequence Number: 16744451
• Product Code: FOZ
• UDI-Device Identifier: 30382903835103
• UDI-Public: 30382903835103
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (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): 02/25/2020

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 Model Number: 383510
• Device Catalogue Number: 383510
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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