MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number	383538
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown device manufacture date: unknown.(b)(4).Investigation summary: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be tracked & trended for future occurrences.Shall a sample or lot number become available, the complaint will be re-opened and an investigation will take place.This complaint will be closed at this time.
Event or Problem Description
It was reported that catheter stayed in vein and split following insertion and hemorrhage occurred upon removal of needle with a bd nexiva¿ closed iv catheter system.The following information was provided by the initial reporter: canula that stays in the vein following insertion had a split.Pt bled from this site immediately upon removal of the needle.Additionally, on 2020-06-06 the bd sales consultant provided the following additional information: what is the batch number? was there serious injury? no, pt bled a bit and a new iv had to be initiated.Were there erroneous results? no.Did the course of treatment change? no.Was there exposure to blood/bodily fluid? yes, to the rn.She was wearing gloves.Was there medical intervention? bleeding was controlled by removing the catheter and putting pressure on the puncture site.Were there any other actions taken? reported incident to the patient care coordinator.

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYSTEM
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10182011
• Report Number: 1710034-2020-00391
• Device Sequence Number: 13674841
• Product Code: FOZ
• UDI-Device Identifier: 30382903835387
• UDI-Public: 30382903835387
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 06/04/2020

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 Model Number: 383538
• Device Catalogue Number: 383545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/22/2020
• 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