MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X1-1/2 RB; PISTON SYRINGE

Model Number	309574
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional 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.(b)(4).
Event or Problem Description
It was reported that covid vaccination medicine leaked from the syringe 3ml ll w/ndl 22x1-1/2 rb and needle connection site during use.The following information was provided by the initial reporter: "the luer-lok connection between the pre-packaged needle and syringe was not securely connected (tightly screwed together), resulting in leakage of diluent from the leur-lok connection.This broke aseptic technique/field and resulted in waste of full vial (which is a loss of 5 covid vaccines).No harm to patient or employee; full vial of pfizer biontech covid-19 vaccine vial was wasted as a result; yes, i retained the bd plastipak 3 ml syringe/needle; i did not see physical defect on inspection, the needle and syringe were not tightly screwed together".
Additional Manufacturer Narrative
H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.
Event or Problem Description
It was reported that covid vaccination medicine leaked from the syringe 3ml ll w/ndl 22x1-1/2 rb and needle connection site during use.The following information was provided by the initial reporter: "the luer-lok connection between the pre-packaged needle and syringe was not securely connected (tightly screwed together), resulting in leakage of diluent from the leur-lok connection.This broke aseptic technique/field and resulted in waste of full vial (which is a loss of 5 covid vaccines).No harm to patient or employee.Full vial of pfizer biontech covid-19 vaccine vial was wasted as a result.Yes i retained the bd plastipak 3 ml syringe/needle.I did not see physical defect on inspection, the needle and syringe were not tightly screwed together".

• Brand Name: SYRINGE 3ML LL W/NDL 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11263879
• Report Number: 1213809-2021-00050
• Device Sequence Number: 3256547
• Product Code: FMF
• UDI-Device Identifier: 30382903095743
• UDI-Public: 30382903095743
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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 Model Number: 309574
• Device Catalogue Number: 309574
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1