MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD CONVENTIONAL SYRINGE; PISTON SYRINGE

Model Number	309656
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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.
Event or Problem Description
It was reported bd conventional syringe had misaligned scale markings.The following information was provided by the initial reporter: "misaligned volume markings and labeling on syringe".
Event or Problem Description
It was reported bd conventional syringe had misaligned scale markings.The following information was provided by the initial reporter: "misaligned volume markings and labeling on syringe".
Additional Manufacturer Narrative
H6: investigation summary: two photos were received and evaluated.One photo showed a label attached to a shelf carton, confirmed to be from batch #8339708 (b)(4) one photo showed a loose 3ml syringe.The scale markings were observed to be severely skewed and only partially printed at a 45 degree angle near the bottom of the barrel.The partial visible markings were between 0.7ml and 2ml.Potential root cause for the scale marking defect is associated with the marking process.The barrel was likely misfed in the marker and presented at an angle to the printing pad.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch 8339708 is considered in compliance with our product specification requirements.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.H3 other text : see h10.

• Brand Name: BD CONVENTIONAL SYRINGE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12751914
• Report Number: 1213809-2021-00744
• Device Sequence Number: 1507088
• Product Code: FMF
• UDI-Device Identifier: 30382903096566
• UDI-Public: 30382903096566
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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,Followup
• Report Date (Section B): 11/04/2021

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: 11/30/2023
• Device Model Number: 309656
• Device Catalogue Number: 309656
• Device Lot Number: 8339708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• 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