MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 20X1 RB; PISTON SYRINGE

Model Number	309578
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the syringe 3ml ll w/ndl 20x1 rb plunger was loose and dispensed medication into the cap.The following information was provided by the initial reporter: "(b)(6), 2020 a bd 3 ml syringe (lot # 0224675) malfunctioned - allowing the plunger to rise and dispense medication into the cap.The needle that was attached was lot # (b)(4).This malfunction resulted in the need to waste 40,000 units of procrit (b)(4).Nobody was injured".
Additional Manufacturer Narrative
H.6.Investigation: 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.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 the syringe 3ml ll w/ndl 20x1 rb plunger was loose and dispensed medication into the cap.The following information was provided by the initial reporter: "friday, (b)(6) 2020 a bd 3 ml syringe (lot # 0224675) malfunctioned - allowing the plunger to rise and dispense medication into the cap.The needle that was attached was lot # 200821b.This malfunction resulted in the need to waste 40,000 units of procrit (lot # g 477168a)] nobody was injured".

• Brand Name: SYRINGE 3ML LL W/NDL 20X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11198422
• Report Number: 1213809-2021-00027
• Device Sequence Number: 11783680
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/20/2021

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 Expiration Date: 07/31/2025
• Device Model Number: 309578
• Device Catalogue Number: 309578
• Device Lot Number: 0224675
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR