MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT 24GA 0.56IN (0.7 MM X 14 MM); INTERVASCULAR CATHETER

Catalog Number 383510

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a bd nexiva single port 24 ga 0.56 in (0.7 mm x 14 mm) had leakage.The following was reported, "material no: 383510, batch no: unknown.It was reported that catheter is shredding during placement.Customer also indicated in follow up email that the catheter leaked at the junction of the j-loop and blue port.'' we are having an issue with the bd nexiva iv cath shredding during placement.I am uncertain of all the detail, so i wanted to reach out to you and get you connected with the appropriate people.Can you provide more details, thank you.Follow up email from customer received on 12/14/2018 states, "with this instance from the other day (i am getting my days confused right now), we went into the patient room after the mom called out and said she thought the patient had pulled his iv out.When we went into the room, the wrapping and bedding were covered in blood.We unwrapped the iv and when we got to the site it had not been pulled out and was still in place.I got a flush to see if i could figure out where the blood was coming from and when i flushed it, water and blood came squirting out of the junction where the connected j-loop meets with the end port (where you screw on the blue port).There was no way to save this iv with this being a closed system.".

Manufacturer Narrative

H.6.Investigation summary: although the review of the dhrs review are required per ms-qs-083, a review could not be performed as the lot number was not provided.One photo was submitted for review.Visual evaluation: photo displayed a nexiva 24ga unit attached with a needless connector.The photo provided for this incident did not reveal any of visible anomalies or damage that would contribute to the alleged defect.Conclusion: indeterminate ¿ without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.

Event Description

It was reported that a bd nexiva single port 24ga 0.56in (0.7 mm x 14 mm) had leakage.The following was reported, "material no: 383510 batch no: unknown.It was reported that catheter is shredding during placement.Customer also indicated in follow up email that the catheter leaked at the junction of the j-loop and blue port.", we are having an issue with the bd nexiva iv cath shredding during placement.I am uncertain of all the detail, so i wanted to reach out to you and get you connected with the appropriate people., can you provide more details.Thank you, follow up email from customer received on 12/14/2018 states, "with this instance from the other day (i am getting my days confused right now), we went into the patient room after the mom called out and said she thought the patient had pulled his iv out.When we went into the room, the wrapping and bedding were covered in blood.We unwrapped the iv and when we got to the site it had not been pulled out and was still in place.I got a flush to see if i could figure out where the blood was coming from and when i flushed it, water and blood came squirting out of the junction where the connected j-loop meets with the end port (where you screw on the blue port).There was no way to save this iv with this being a closed system.".

• Brand Name: BD NEXIVA SINGLE PORT 24GA 0.56IN (0.7 MM X 14 MM)
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8460943
• MDR Text Key: 143598949
• Report Number: 1710034-2019-00341
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835103
• UDI-Public: 30382903835103
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383510
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other