MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number 309657

Device Problem Defective Component (2292)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that the bd luer-lok plunger rod was broken/damaged.The following information was provided by the initial reporter: "several incidents while using the 3ml syringes for 1ml im injections that we have in the clinic where the plunger does not fully depress.It¿s almost like it gets stuck and will not advance past the 0.5ml mark.Today, the plunger completely broke and half the dose of medication went back into the syringe chamber.".Additional information provided by customer: hello, thank you for the response.Please find my answers to your questions below.1.Are you able to provide the dates of the events in the format of mm-dd-yyyy? i have had at 5 occurrences of the syringe stopping at approximately the 0.5ml mark.These have happened intermittently between 08-01-2023 and 02-21-2024 the most recent occurrence was wednesday, 02-21-2024 2.How was the patient outcome? are there any clinical signs, health consequences or impact? patient outcome was fine, but i did have to administer two doses of medication for the latest incident on 02-21-2024.3.Any adverse event or serious injury reported to patient or health care professional? no serious injury to patient or professional.4.Any physical sample or photo available for investigation of affected product? if yes, are you able to provide the address of the facility for us to ship the return label? there are no photographs or samples available to send as they were used for im administration and have been disposed of.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD LUER-LOK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18942466
• MDR Text Key: 339222603
• Report Number: 1213809-2024-00172
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• 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: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309657
• Device Lot Number: 2209583
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1