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

Model Number 309581

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

It was reported while using bd luer-lok¿ syringe with attached needle the plunger rod was difficult to move and the syringe leaked.There was no report of patient impact.The following information was provided by the initial reporter: material no.309581 batch no.9296333.Consumer reported needles dull.Bleeding at the injection site during injection.Plunger rod difficult to move.Medication leaking (b-12) from syringe, around the needle hub.Consumer stated that she tightens the needle onto the syringe before using.She stated that she does it to make sure that the needle does not loosen while injecting.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Unused physical samples from the complaint batch are needed to confirm the noted defects.Please also make sure that needles are not overtightened onto the syringe when hand-tightening.Overtightening can potentially lead to leakage.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.We appreciate you taking the time to bring this observation to our attention.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.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Unused physical samples from the complaint batch are needed to confirm the noted defects.Please also make sure that needles are not overtightened onto the syringe when hand-tightening.Overtightening can potentially lead to leakage.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Unused physical samples from the complaint batch are needed to confirm the noted defects.Please also make sure that needles are not overtightened onto the syringe when hand-tightening.Overtightening can potentially lead to leakage.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.We appreciate you taking the time to bring this observation to our attention.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.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Unused physical samples from the complaint batch are needed to confirm the noted defects.Please also make sure that needles are not overtightened onto the syringe when hand-tightening.Overtightening can potentially lead to leakage.

Event Description

It was reported while using bd luer-lok¿ syringe with attached needle the plunger rod was difficult to move and the syringe leaked.There was no report of patient impact.The following information was provided by the initial reporter: material no.309581 batch no.9296333.Consumer reported needles dull.Bleeding at the injection site during injection.Plunger rod difficult to move.Medication leaking (b-12) from syringe, around the needle hub.Consumer stated that she tightens the needle onto the syringe before using.She stated that she does it to make sure that the needle does not loosen while injecting.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE
• 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: 13337758
• MDR Text Key: 285414732
• Report Number: 1213809-2022-00014
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095811
• UDI-Public: 30382903095811
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309581
• Device Catalogue Number: 309581
• Device Lot Number: 9296333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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