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

Catalog Number 383517

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that bd nexiva single port needle difficult to disengage from catheter.The following information was provided by the initial reporter, translated from chinese to english: ct room before use, up and down when loosening the needle core , the needle core jam blunt too tight, there are photos, can return samples, need to green claims.

Manufacturer Narrative

Our quality engineer inspected the representative samples submitted for evaluation.Bd received one unsealed unit of a 20gx1.00in nexiva device from lot number 3116949.A gross visual inspection shows that the unit has not been disengaged and no physical damage could be observed.Your reported issue of a tight fit between the needle and safety mechanism was confirmed and the cause appeared to be manufacturing related.One 20g nexiva device was provided for investigation.The washer within the tip shield safety mechanism appeared to be misaligned, which created resistance when it was moved over the needle shaft.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD NEXIVA 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: 18992961
• MDR Text Key: 339139686
• Report Number: 1710034-2024-00251
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: (01)30382903835172
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 03/27/2024

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: Health Professional
• Device Catalogue Number: 383517
• Device Lot Number: 3116949
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Type of Device Usage: Initial
• Patient Sequence Number: 1