MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G; PISTON SYRINGE

Model Number	309582
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.6.Investigation summary: three samples were provided to our quality team for investigation.The reported issue was not confirmed upon inspection of the samples.None of the samples showed any signs of the reported defect.Since the reported defect was not confirmed a manufacturing root cause could not be determined.Furthermore, a device history record review was completed for provided lot number 0351028, 0351034 and 0351036.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3: see h.10.
Event or Problem Description
It was reported while using bd luer-lok¿ syringe with attached needle 25 g the needle pulled out of the hub.There was no report of patient impact.The following information was provided by the initial reporter: mds- bd plastipak 3ml syringes 309582.Twice the needle pop off the syringe while instilling the diluent into the covid vial, causing the diluent to squirt out onto the counter.Twice we have had the needles pop off the syringe while instilling the diluent into the covid vial, causing the diluent to squirt out onto the counter.We have had to waste two vials of vaccine because we did not know how much diluent was injected into the covid vial and how much squirted out when the needle popped off the syringe.Are you able to provide the date of occurrence for each incident? i am not- though it happened twice in 1 week.Is sample available to return for investigation? yes.Was the patient involved in this incident? if yes, what was the patient outcome? no.Were you able to correct the issue by using another needle or giving it a little twist- we tried that after the first incident and that did not solve the problem.I am not sure which lot number that the occurrence happened to (i have multiple lot numbers).I have collected all of the bd plastipak 3ml syringe with 25g 1 1/2 needle.I made the decision not to use any of the needle/syringe combo.I did not want to waste anymore covid vaccine.¿.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G
• Common Device Name: 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 ; 8448235433
• MDR Report Key: 16883449
• Report Number: 1213809-2023-00467
• Device Sequence Number: 17572315
• Product Code: FMF
• UDI-Device Identifier: 30382903095828
• UDI-Public: (01)30382903095828
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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
• Operator of Device: Other
• Device Expiration Date: 11/30/2025
• Device Model Number: 309582
• Device Catalogue Number: 309582
• Device Lot Number: 0351034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 05/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown