MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LS 200 S/C; PISTON SYRINGE

Catalog Number	309656
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2019
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 that scale marking error occurred with a syringe 3ml ls 200 s/c.The following information was provided by the initial reporter, "the lines for measuring are not printed on the syringes.".
Additional Manufacturer Narrative
Investigation: three photos were received and evaluated.Two photos displayed a total of four 3ml syringes with varying degrees of rolled scale and missing scale.One photo showed a 200-count label from batch 9002521 (p/n 309656).The missing scale was rejectable per product specification.Potential root cause for the missing print is associated with the printing process.It is likely a printing component gradually slipped out of adjustment causing the print to be applied on the incorrect position on the barrel.This is consistent with the variance of the missing scale.The potential root cause for the product being distributed is associated with insufficient containment.The missing print was discovered during manufacturing and containment actions were administered but defective product was still packaged and distributed.The printing components involved in the rolled scale were replaced 10/14/2019.For insufficient containment, corrective and preventive action, capa#753644, was opened and implemented 8/26/2019.
Event or Problem Description
It was reported that scale marking error occurred with a syringe 3ml ls 200 s/c.The following information was provided by the initial reporter, "the lines for measuring are not printed on the syringes.".

• Brand Name: SYRINGE 3ML LS 200 S/C
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9147852
• Report Number: 1213809-2019-00995
• Device Sequence Number: 11228750
• Product Code: FMF
• UDI-Device Identifier: 30382903096566
• UDI-Public: 30382903096566
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 309656
• Device Lot Number: 9002521
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other