MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/BLUNT PLASTIC CANN; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303346
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 3ml ll w/blunt plastic cann was missing scale markings on 6 occasions.The following information was provided by the initial reporter: material no: 303346, batch no: 0087141.It was reported that: customer noticed scale markings missing from barrel of syringe.
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, therefore a root cause could not be determined.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.
Event or Problem Description
It was reported that syringe 3ml ll w/blunt plastic cann was missing scale markings on 6 occasions.The following information was provided by the initial reporter: material no: 303346 batch no: 0087141.It was reported that: customer noticed scale markings missing from barrel of syringe.

• Brand Name: SYRINGE 3ML LL W/BLUNT PLASTIC CANN
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10830722
• Report Number: 1213809-2020-00793
• Device Sequence Number: 16859598
• Product Code: FMI
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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): 11/17/2020

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: 02/28/2025
• Device Model Number: 303346
• Device Catalogue Number: 303346
• Device Lot Number: 0087141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1