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

Catalog Number 309628

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the plunger in the bd luer-lok¿ tip syringe was loose while drawing up canukinumab, causing it to leak out of the barrel during use.The following information was provided by the initial reporter: "staff member attempted to draw up canukinumab 150mg s/c using 1ml syringe as per drug guidelines.There was no resistance in the syringe plunger and it came out of the barrel of the syringe wasting the drug.".

Manufacturer Narrative

Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.According to verbatim, the complaint appears to be for the absence of retaining ring in the syringe barrel.This product does not have a retaining ring by design according to its product specification.Dhr review is not required due to the complaint being for the design of the product and not a true defect.H3 other text : see h10.

Event Description

It was reported that the plunger in the bd luer-lok¿ tip syringe was loose while drawing up canukinumab, causing it to leak out of the barrel during use.The following information was provided by the initial reporter: "staff member attempted to draw up canukinumab 150mg s/c using 1ml syringe as per drug guidelines.There was no resistance in the syringe plunger and it came out of the barrel of the syringe wasting the drug.".

• Brand Name: BD LUER-LOK¿ TIP SYRINGE
• 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 ; 8015296192
• MDR Report Key: 15799092
• MDR Text Key: 307794563
• Report Number: 1213809-2022-00986
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: (01)00382903096282
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 309628
• Device Lot Number: 9092988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2019
• 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