MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SALINE XS; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Leak/Splash (1354)

Patient Problem Dizziness (2194)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

Materials#: 306572 batch#: 3131602.It was reported by the customer that the blood sent through the rubber inside trickled down the plunger to his hand as well as some bubbles that went into the line.Verbatim: rcc received a complaint via email.Email(s) attached.Chc complaint reference # (b)(4) customer (hospital) name: (b)(6).Customer address: (b)(6).Contact name: (b)(6).Phone: (b)(6).E-mail: (b)(6).Correspondence language: english cat# of product being complained: bd306572 description of product: syringe saline xs p/flush 10ml 30ea/bx 8bx/ca lot or s/n: (b)(6).Complaint category: fail to function / defective reportable: no incident date: (b)(6) 2023 hospital complaint reference #: details of complaint (reported issue): on 1 dec 2023, a nurse emailed a baxter customer care representative to report a 10cc syringe (product code: loc17858, lot number: 3131602) that seemed to be defective.This incident was reported to the nurse by a patient who was accessing/ flushing his cvc line.He noticed that the blood sent through the rubber inside trickled down the plunger to his hand as well as some bubbles that went into the line.The syringe was replaced right away by the patient; however, he felt some dizziness in this process but no injuries were reported.The patient called 911 for an emergency, and his oxygen levels, blood pressure, and ecg were checked which came out to be normal.The patient felt better eventually.Complaint noticed: during / after use problem frequency: 1st time customer exposure: patient injury: yes.Has health canada been informed? unknown.Qty affected: 1 ea samples available? no.Is customer requesting an rga?: no.

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.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 3131602.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As neither physical samples nor picture samples were available for return, a thorough sample analysis could not be completed.If the affected samples become available for this incident or any potential future incidents, we would greatly appreciate the opportunity to review them.Based on the investigation results, an exact cause could not be determined for the reported event.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

No additional information.

• Brand Name: SYRINGE 10ML SALINE XS
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18564195
• MDR Text Key: 333496852
• Report Number: 1911916-2024-00033
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306572
• Device Lot Number: 3131602
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1