MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SYRINGE 5ML LL W/NDL 21X1 RB; PISTON SYRINGE

Model Number	309632
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.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 5ml ll w/ndl 21x1 rb had no scale markings on it.This complaint was created to capture the 5th of 7 related incidents.The following information was provided by the initial reporter: "no writing on syringes".
Additional Manufacturer Narrative
H.6.Investigation: three opened resealed shelf cartons were received with labels from batch #0209102 (p/n 309632).The samples were visually evaluated.217 samples were found to have no scale markings on the barrels.They appeared to not have been printed at all.69 samples were observed to have correct and complete scale markings with no defects.Potential root cause for the missing print defect is associated with the marker setup and failure to contain defect.It is possible during adjustments, there was no print transfer between the pad and the barrel.This is likely due to incomplete setup while the setup was still being worked on.Failure to contain defect.The unmarked barrels were discarded at first via automatic scrap diverter at machine startup.However, since the adjustments were likely not completed the defect continued to be made while the discard diverter automatically returned the parts into the normal product flow.Dhr was performed.All visual inspections were performed as per requirement.A quality notification was issued for print defects during the manufacture of this batch.
Event or Problem Description
It was reported that the syringe 5ml ll w/ndl 21x1 rb had no scale markings on it.This complaint was created to capture the 5th of 7 related incidents.The following information was provided by the initial reporter: "no writing on syringes.".

• Brand Name: SYRINGE 5ML LL W/NDL 21X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11198425
• Report Number: 1213809-2021-00025
• Device Sequence Number: 4086094
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: 30382903096320
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 06/30/2025
• Device Model Number: 309632
• Device Catalogue Number: 309632
• Device Lot Number: 0209102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1