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

Model Number 309628

Device Problem Connection Problem (2900)

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

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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.

Event Description

It was reported that the bd luer-lok¿ tip syringe was damaged.The following information was provided by the initial reporter: "a12 - connection problem".

Manufacturer Narrative

After additional information has been received and reviewed, it has been determined that this event is unlikely to cause harm/serious injury to a patient/device operator.The initial mdr submission, may therefore be disregarded.B5.Describe event or problem: it was reported that the bd luer-lok¿ tip syringe had issues with connection and aspiration.Both of which would not lead to any degree of harm/serious injury.The following information was provided by the initial reporter: faulty syringe and filter needle connection when attempting to draw up epinephrine from the emergency epinephrine kits for anaphylaxis.Two separate attempts using other emergency kit bags opened to obtain a needle/syringe - eventually successful in drawing up the epinephrine dose.No negative outcome even with a small delay.H3 other text : see h10.

Event Description

It was reported that the bd luer-lok¿ tip syringe had issues with connection and aspiration.Both of which would not lead to any degree of harm/serious injury.The following information was provided by the initial reporter: faulty syringe and filter needle connection when attempting to draw up epinephrine from the emergency epinephrine kits for anaphylaxis.Two separate attempts using other emergency kit bags opened to obtain a needle/syringe - eventually successful in drawing up the epinephrine dose.No negative outcome even with a small delay.

• 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: 12329158
• MDR Text Key: 266870462
• Report Number: 1213809-2021-00569
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/30/2022

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: 309628
• Device Catalogue Number: 309628
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/16/2021
• Supplement Dates Manufacturer Received: 08/31/2022
• Supplement Dates FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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