MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK 1 ML; PISTON SYRINGE

Model Number 309628

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/15/2021

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: four photos were received and evaluated.The photos showed a loose 1ml ll syringe in a customer¿s hand.The syringe was partially filled with clear liquid to about 0.3ml line in one photo and 0.7ml in three photos.Leakage past stopper was observed in some of the photos.One photo showed what appeared to be distorted/jammed stopper on one side stretched up the barrel past the plunger rod tip.Potential root cause for the leakage past stopper defect is associated with the jammed stopper condition due to an issue during the assembly process.Jammed stopper may not form appropriate seal with the barrel wall and can result in leakage.The lot number is unknown, therefore defective rate cannot be identified.Lot number is required to determine if corrective actions are necessary.No corrective actions will be taken based on the available information.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

Bd luer-lok¿ 1 ml.Material no.: 309628 batch no.: unknown.It was reported that syringes are leaking.Verbatim: 309628 - leakage past stopper.

• Brand Name: BD LUER-LOK 1 ML
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11823531
• MDR Text Key: 250825496
• Report Number: 1213809-2021-00321
• 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: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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
• Date Manufacturer Received: 04/15/2021
• 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: N
• Patient Sequence Number: 1