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

Model Number 309628

Device Problem Volume Accuracy Problem (1675)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: the issue described in the complaint appears to pertain to what is known as dead space.Dead space does not affect volumetric accuracy of the syringe.This product is manufactured and sold in accordance with international organization for standardization (iso) 7886-1.The amount of dead space allowed for this product size is 0.07ml.The reported quantity of 0.04ml is well within the accepted dead space volume per product specification.Since no samples displaying the reported condition were received the alleged defect could not be confirmed and corrective actions are not necessary.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported when using the bd luer-lok¿ tip syringe there was an issue with the syringe - volumetric accuracy.The following information was provided by the initial reporter.The customer stated: "after administration of medication the nurse noticed that 0.04 ml remained in the syringe.It was only after she had placed the injection and pushed the plunger down, that she noticed the syringe was not empty.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12502897
• MDR Text Key: 273152016
• Report Number: 1213809-2021-00644
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 309628
• Device Catalogue Number: 309628
• Device Lot Number: 0321677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• 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