MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 22 GA X 1 IN SINGLE PORT; PERIPHERAL IV CATHETERS

Catalog Number 383512

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the nexiva 22 ga x 1 in single port extension tubing, and connector was damaged.The following information was provided by the initial reporter, translated from japanese to english: customer reported that it was placed on the dorsum of the foot and there is a high possibility that, it caught in the patient's leg and pulled.Damage to extension tube and connector part.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: the complaint of a damaged extension tube was confirmed and the cause appeared to be associated with use.Five photographs and one 22g nexiva device were provided for investigation.The extension tubing completely broke at the distal end of the luer adapter.A piece of tubing remained adhered within the luer adapter.The adjoining surfaces of the tubing were rough and jagged, which is consistent with a break.It was reported that the tubing was likely caught and pulled during use.No damage associated with the manufacturing process was identified on the returned sample.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion(s): the complaint of ¿tubing damaged/defective¿ was confirmed.As the extension tubing broke and a piece of the extension tube remained adhered within the luer adapter, 'tubing damaged/defective' was used as the as analyzed code to distinguish the failure mode from a complete separation (without a break) of the extension tubing from the luer adapter.Probable root cause conclusion(s): use related.

• Brand Name: BD NEXIVA 22 GA X 1 IN SINGLE PORT
• Type of Device: 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: 18530268
• MDR Text Key: 333097009
• Report Number: 1710034-2024-00018
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835127
• UDI-Public: (01)30382903835127
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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
• Device Operator: Other
• Device Catalogue Number: 383512
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1