MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G; PISTON SYRINGE

Model Number 309582

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd luer-lok¿ syringe with attached needle 25 g there were connection issues and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: i mentioned to her that the bd 3ml 25g 1 1/2 syringe/needle that sometimes came with the pediatric ancillary kit actually did not have the needle part firmly affixed to the syringe.The saline solution can leak out from the side of the syringe where the needle and the syringe meet.I thought that was the way it comes in and that we just have to be more careful to make sure the needle is affixed to the syringe firmly before using it.The affected vaccines were reported as waste and were never used for immunization.Nobody received an incorrect dose as a result.The nurse told me this is actually considered a defect and i should report it.The lot numbers that we have are 0351034, 0351032, and 0351028.The total quantity is about 50 and they are already set aside in a bag and marked "do not use'.

Manufacturer Narrative

H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot numbers that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

Event Description

It was reported while using bd luer-lok¿ syringe with attached needle 25 g there were connection issues and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: verbatim: i mentioned to her that the bd 3ml 25g 1 1/2 syringe/needle that sometimes came with the pediatric ancillary kit actually did not have the needle part firmly affixed to the syringe.The saline solution can leak out from the side of the syringe where the needle and the syringe meet.I thought that was the way it comes in and that we just have to be more careful to make sure the needle is affixed to the syringe firmly before using it.The affected vaccines were reported as waste and were never used for immunization.Nobody received an incorrect dose as a result.The nurse told me this is actually considered a defect and i should report it.The lot numbers that we have are 0351034, 0351032, and 0351028.The total quantity is about 50 and they are already set aside in a bag and marked "do not use'.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16659531
• MDR Text Key: 312523017
• Report Number: 1213809-2023-00299
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095828
• UDI-Public: (01)30382903095828
• 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: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309582
• Device Catalogue Number: 309582
• Device Lot Number: 0351028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1