MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB; PISTON SYRINGE

Model Number	305905
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: one photo of a loose 3ml syringe was received and evaluated.It was observed the printed scale on the barrel was very light with most of the scale also blurred, which was rejectable pre product specification.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.Potential root cause for the poor print defect is associated with the marking process.No corrective actions are necessary based on the defective rate identified.Batch 9304558 is considered in compliance with our product specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: potential root cause for the poor print defect is associated with the marking process.The aql for poor print quality is 0.25%.(b)(4).No corrective actions are necessary based on the defective rate identified.Batch 9304558 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that the syringe 3ml ll w/ndl sftygld 23x1 rb experienced scale marking issues and illegible scale markings.The following information was provided by the initial reporter: the scale is blurr.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10857321
• Report Number: 1213809-2020-00810
• Device Sequence Number: 19454599
• Product Code: FMF
• UDI-Device Identifier: 30382903059059
• UDI-Public: 30382903059059
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: 09/30/2024
• Device Model Number: 305905
• Device Catalogue Number: 305905
• Device Lot Number: 9304558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1