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

Catalog Number	309632
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 5ml ll w/ndl 21x1 rb had no scale markings.The following information was provided by the initial reporter: material no: 309632, batch no: 0209102.  it was reported that there were no markings.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/15/2021.H.6.Investigation: eighty-one 5ml syringes with needles attached, in blister packs from batch 0209102 (p/n 309632) were received and evaluated.Eighty of the packages were fully sealed and one was opened.It was observed seventy-nine of the syringes had no visible scale markings, which was rejectable per product specification.Potential root cause for the missing print defect is associated with the marker setup and failure to contain defect.(1) 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.(2) failure to contain defect.The unmarked barrels were discarded at first via automatic scrap diverter at machine startup.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.Product was requalified per applicable aql.Batch 0209102 (309632) was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.
Event or Problem Description
It was reported that syringe 5ml ll w/ndl 21x1 rb had no scale markings.The following information was provided by the initial reporter: material no: 309632, batch no: 0209102.  it was reported that there were no markings.

• Brand Name: SYRINGE 5ML LL W/NDL 21X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11572606
• Report Number: 1213809-2021-00169
• Device Sequence Number: 4266187
• Product Code: FMF
• UDI-Device Identifier: 00382903096329
• UDI-Public: 00382903096329
• 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
• 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): 03/30/2021

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 Catalogue Number: 309632
• Device Lot Number: 0209102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1