MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD UNDISCLOSED PREFILLED SYRINGE; SALINE VASCULARE ACCESS FLUSH

Catalog Number UNKNOWN

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.D.The material and/or lot number provided have not been found and cannot be verified.In this mdr, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1 as the manufacturing site is unknown.

Event Description

It was reported that bd undisclosed prefilled syringe leaked at the connection.The following information was provided by the initial reporter, translated from chinese to english: nurses leak fluid when flushing patients because of poor connection, which affects the patient's therapeutic effect.

Manufacturer Narrative

Additional information confirming no negative patient outcome received.Investigation: a complaint history review cannot be performed as no material and batch/lot number was provided.A dhr review cannot be performed as no material and batch/lot number was provided.Based on limited information available after multiple unsuccessful attempts to obtain - unable to assess the rm documentation.Root cause couldn't be determined due to unavailability of sample/material/lot number information.

Event Description

Additional information received: hello, i have consulted the hospital, the equipment department has not been able to obtain sample information, and at the same time asked the department that uses the irrigator, they have no impression that there has been a situation that affects the treatment.

• Brand Name: BD UNDISCLOSED PREFILLED SYRINGE
• Type of Device: SALINE VASCULARE ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL, MEDICATION DELIVERY SOLUTIONS; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18187571
• MDR Text Key: 329091756
• Report Number: 1423507-2023-00108
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1