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

Model Number	383579
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 1 bd nexiva closed iv catheter had tubing separation.The following information was provided by the initial reporter : the user reported that an rn started an iv for a patient and the plastic tubing separated from the winged portion of the iv hub and it detached after pulling back to retract the needle.The rn reported that blood starting pouring out of the small port to the right of the hub.Date of event : (b)(6) 2022.Sample availability : available.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 29-mar-2022.H6: investigation summary a device history record review was completed for provided material number 383579 and lot number 1293719.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, the affected sample was returned for evaluation by our quality engineer team.Through examination of the sample, disconnection of the tubing was observed and we were able to detect a lack of dispensing adhesive on the tube component.The assembly process for this product is carried out manually with an evaluation for correct assembly performed.A tug test inspection is performed by the operator to ensure that the product meets acceptance criteria.Although we were unable to identify any documented issues during the production and inspection processes, we have concluded that this incident resulted due to a lack of adhesive and an incorrect performance of the tug test during the manufacturing process.H3 other text : see h10.
Event or Problem Description
It was reported that 1 bd nexiva closed iv catheter had tubing separation.The following information was provided by the initial reporter : the user reported that an rn started an iv for a patient and the plastic tubing separated from the winged portion of the iv hub and it detached after pulling back to retract the needle.The rn reported that blood starting pouring out of the small port to the right of the hub.Date of event : (b)(6)2022.Sample availability : available.

• Brand Name: BD NEXIVA CLOSED IV CATHETER
• Common Device Name: INTRAVASCULAR 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14073380
• Report Number: 1710034-2022-00179
• Device Sequence Number: 2632226
• Product Code: FOZ
• UDI-Device Identifier: 00382903835799
• UDI-Public: 00382903835799
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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 Expiration Date: 10/31/2024
• Device Model Number: 383579
• Device Catalogue Number: 383579
• Device Lot Number: 1293719
• 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: 03/19/2022
• Supplement Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown