MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA; PERIPHERAL IV CATHETERS

Catalog Number	383531
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva, tubing separated from adapter.The following information was provided by the initial reporter: patient was receiving taxol via left ivl in the underarm.Tubing from the plastic iv insertion snapped off leading to chemo and blood spill onto patient's left rib and left hip.No irritation present on skin and patient endorsed feeling okay.No adverse event or serious injury reported.No patient impact.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation findings: our quality engineer inspected the photographs and sample submitted for evaluation.Bd received one photo and one unit of a 24gx0.75in nexiva device from an unknown lot for the investigation of this complaint.The unit on the photo appears to be the physical unit that was returned.A gross visual inspection shows that only part of the device was returned.The extension tubing that is attached to the y-adapter of two q-sytes.No sign of used is observed on the device though the other end of the extension tubing is separated from the joint of the wing adapter.The unit was investigated by looking for the presence of adhesive on the extension tubing, there was no adhesive on the extending tubing.The end of the tubing was also investigated for any striation and none was found therefore indicating that the lack of adhesive around the joint likely caused the reported complaint.The reported nonconformance was confirmed.This was the physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to an operator error in the packaging process.This type of defect may occur during manufacturing due to a misalignment the adhesive distribution station.The appropriate manufacturing personnel were notified of this complaint.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD NEXIVA
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19486024
• Report Number: 1710034-2024-00526
• Device Sequence Number: 18119181
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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 Catalogue Number: 383531
• Device Lot Number: UNKNOWN
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown