MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS UNSPECIFIED BD 3ML LUER-LOK SYRINGE; PISTON SYRINGE

Catalog Number	UNKNOWN
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 there were scale marking issues with a bd syringe 3ml ll¿ w/ndl 20x1 rb.The following information was provided by the initial reporter: it was reported that the measurements on the syringe are incorrect.Details of complaint (reported issue): identification measurement is incorrect a can lead to danger of wrong dosage.
Additional Manufacturer Narrative
The following fields have been updated with additional information: medical device brand name: unspecified bd 3ml luer-lok syringe.Medical device catalog #: unknown.Medical device lot #: unknown.Medical device expiration date: unknown.Unique identifier (udi) #: unknown.Pma / 510(k)#: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that there were scale marking issues with a bd syringe 3ml ll¿ w/ndl 20x1 rb.The following information was provided by the initial reporter: it was reported that the measurements on the syringe are incorrect.Details of complaint (reported issue): identification measurement is incorrect a can lead to danger of wrong dosage.
Additional Manufacturer Narrative
Investigation: photo received does not match the event description information reported by the customer.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
It was reported that there were scale marking issues with a bd syringe 3ml ll¿ w/ndl 20x1 rb.The following information was provided by the initial reporter: it was reported that the measurements on the syringe are incorrect.Details of complaint (reported issue): identification measurement is incorrect a can lead to danger of wrong dosage.

• Brand Name: UNSPECIFIED BD 3ML LUER-LOK SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8566221
• Report Number: 1213809-2019-00490
• Device Sequence Number: 1666996
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNKNOWN
• 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,Followup
• Report Date (Section B): 05/30/2019

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: 11/30/2023
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019; 04/15/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 05/24/2019; 05/30/2019
• 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