MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE ORAL 3ML CLEAR; SYRINGE, PISTON

Catalog Number 305220

Device Problem Defective Component (2292)

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

Event Date 12/13/2023

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.B3.The date received by manufacturer has been used for this field.

Event Description

It was reported that bd syringe oral 3ml clear stopper was defective / damaged it was reported by customer that they have had to dispose of several of our syringes already from one bag because the rubber part inside is crooked and makes his dosage inaccurate.Verbatim: rcc received a complaint via phone.Pir attached.Hello, my son is a transplant recipient and relies on accurate medication dosages.I have had to dispose of several of your syringes already from one bag because the rubber part inside is crooked and makes his dosage inaccurate.

• Brand Name: BD SYRINGE ORAL 3ML CLEAR
• Type of Device: SYRINGE, PISTON
• 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: 18455008
• MDR Text Key: 332200739
• Report Number: 1213809-2023-01514
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 305220
• Device Lot Number: 1323425
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• 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