MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 60ML SYRINGE LUER-LOK TIP; PISTON SYRINGE

Model Number 309657

Device Problem Leak/Splash (1354)

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

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

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.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.Examination of the product involved may provide clarification as to the cause for the reported failure.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.Investigation conclusion: since no samples displaying the reported condition were received a potential root cause could not be defined.Since no samples displaying the reported condition were received corrective actions are not necessary.

Event Description

It was reported that 3 bd 60ml syringe luer-lok¿ tips experienced a failure to contain medication.The following information was provided by the initial reporter: on three separate occasions a nurse was using 3ml syringe to draw saline.Same was done and then nurse went to inject saline into the vial of covid vaccine.The syringe cracked down the side and saline leaked out.On one occasion this lead to the vial being wasted as the amount of saline injected into vial vs.What was lost could not be determined.On the other two occasions same was noted before injection occurred.We stopped using the lot # associated with the first incident and same has occurred through different lots# since.Level of harm: no effect - did not reach patient - detected before use or does not touch person during use.

• Brand Name: BD 60ML SYRINGE LUER-LOK TIP
• 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: 12547009
• MDR Text Key: 273788582
• Report Number: 1213809-2021-00677
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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: 0079124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• 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: Initial
• Patient Sequence Number: 1