MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303401
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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 has been reported that one bd 3ml syringe with luer-lok tip with vial access cannula has been found experiencing scale marking issues before use.The following has been provided by the initial reporter: it was reported that "the syringes have no markings on them".The syringes have no markings on them.
Additional Manufacturer Narrative
H.6.Investigation summary: two photos were received and evaluated.The photos depicted a single sealed packaged 3ml syringe, confirmed to be from batch #9014529 (p/n 303401).The syringe appeared to have no scale markings at all printed on the barrel.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 missing print defect is associated with the marking process.No corrective actions are necessary based on the defective rate identified.Batch 9014529 is considered in compliance with our product specification requirements.
Event or Problem Description
It has been reported that one bd 3ml syringe with luer-lok tip with vial access cannula has been found experiencing scale marking issues before use.The following has been provided by the initial reporter: it was reported that "the syringes have no markings on them".Customer text: the syringes have no markings on them.

• Brand Name: BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9141740
• Report Number: 1213809-2019-00989
• Device Sequence Number: 419004
• Product Code: FMI
• UDI-Device Identifier: 30382903034018
• UDI-Public: 30382903034018
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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 Catalogue Number: 303401
• Device Lot Number: 9014529
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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