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

Model Number 309657

Device Problem Partial Blockage (1065)

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

Event Date 10/30/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd luer-lok¿ tip disposable syringe needle became blocked at the.5ml mark and the plunger was difficult to move.This occurred 2 separate times during use.The following information was provided by the initial reporter: "when infusing medication in 3ml syringe via medfusion syringe pump, pump rings occludded at 0.5 ml volume remaining.?plunger stiff.When pulled back to fill syringe issue appears to have resolved.This is the first reported incident, however the note left by the staff reported states it has been happening for a few weeks.The syringe was prepared and delivered with the medication ready to administer by pharmacy and thus lot number is unknown.".

Event Description

It was reported that the bd luer-lok¿ tip disposable syringe needle became blocked at the.5ml mark and the plunger was difficult to move.This occurred 2 separate times during use.The following information was provided by the initial reporter: "when infusing medication in 3ml syringe via medfusion syringe pump, pump rings occludded at 0.5 ml volume remaining.?plunger stiff.When pulled back to fill syringe issue appears to have resolved.This is the first reported incident, however the note left by the staff reported states it has been happening for a few weeks.The syringe was prepared and delivered with the medication ready to administer by pharmacy and thus lot number is unknown.".

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/22/2021.H.6.Investigation: one photo and one loose 3ml syringe (p/n 309657) were received.The sample was visually evaluated and tested for both functionality and volumetric accuracy.No visible defects were observed on the syringe and the sample yielded acceptable results for volumetric accuracy, along with being able to properly expel the fluid.The sample was acceptable per product specification requirements.No claims can be made about the syringe pump as it is not a bd product.Since the sample received did not display the reported defect a potential root cause could not be defined and corrective actions are not necessary.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see h.10.

Event Description

It was reported that the bd luer-lok¿ tip disposable syringe needle became blocked at the.5ml mark and the plunger was difficult to move.This occurred 2 separate times during use.The following information was provided by the initial reporter: "when infusing medication in 3ml syringe via medfusion syringe pump, pump rings occludded at 0.5 ml volume remainging.Plunger stiff.When pulled back to fill syringe issue appears to have resolved.This is the first reported incident, however the note left by the staff reported states it has been happening for a few weeks.The syringe was prepared and delivered with the medication ready to administer by pharmacy and thus lot number is unknown.".

• Brand Name: BD LUER-LOK¿ TIP DISPOSABLE 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: 13003581
• MDR Text Key: 285405212
• Report Number: 1213809-2021-00813
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• 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: 01/05/2022

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 Model Number: 309657
• Device Catalogue Number: 309657
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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