MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN SALINE FLUSH; SALINE, VASCULAR ACCESS FLUSH

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Event Description

Material #:unknown.Batch#:unknown.It was reported by customer that when verification of patency of hemodialysis catheter, there was a leak around the plunger and blood came out the syringe (small quantity).Verbatim: when verification of patency of hemodialysis catheter, there was a leak around the plunger and blood came out the syringe (small quantity).Sample saved? no.Biohazard sample? no.What was the patient outcome? minor blood loss but a risk of infection as the syringe seal (plugger) is compromise? nothing happen majors to the 3 patients.Was there any delay of, or change in, the course of treatment due to this event? slight as we had to get another syringe what procedure was being performed? verification of patency of hemodialysis catheter.What medication was used in the procedure? none.Was there any medical intervention due to this event? no.Has this event resulted in a serious injury to the patient or medical staff? no.Has this event resulted in a change during treatment? no, used a different syringe.Has this event resulted in exposure of medical staff to the blood of the patient? no as the blood didn¿t splatter.If so, was medical intervention offered or provided in the form of medication or screening? no.Has this event resulted in a needle stick? no.

• Brand Name: UNKNOWN SALINE FLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18768121
• MDR Text Key: 336977936
• Report Number: 1911916-2024-00142
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 01/25/2024
• 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