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	09/19/2019
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 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 before use, the syringe 3ml ls 200 s/c was observed with missing scale markings.The following information was provided by the initial reporter: 1 box (309656) missing scale markings on syringes.
Event or Problem Description
It was reported that before use, the syringe 3ml ls 200 s/c was observed with missing scale markings.The following information was provided by the initial reporter: 1 box (309656) missing scale markings on syringes.
Additional Manufacturer Narrative
Investigation summary: two photos and five 3ml syringes in fully sealed blister packs confirmed to be from batch 9002521 (p/n 309656).Were received and evaluated.It was observed two of the syringes contained the scale marking and no grad lines.Two syringes contained half of all the scale marking with no grad lines.One syringe was nearly completely blank.The missing print observed was rejectable per product specification during production of the reported batch, an issue was identified and additional measures were taken to assure release of the product.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, capa 753644 was opened and implemented 8/26/2019.

• 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: 9167735
• Report Number: 1213809-2019-01013
• Device Sequence Number: 2272593
• 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): 12/03/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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