MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK SYRINGE W/ PRECISIONGLIDE NEEDLE; SYRINGE AND NEEDLE

Catalog Number	309578
Medical Device Problem Codes	Volume Accuracy Problem (1675); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd luer-lok¿ syringe w/ precisionglide¿ needle had scale marking issues and foreign matter in the barrel.The following information was provided by the initial reporter: material no: 309578, batch no: unknown.It was reported that graduation marks do not stick well and surface of barrel is waxy.
Event or Problem Description
It was reported that bd luer-lok¿ syringe w/ precisionglide¿ needle had scale marking issues and foreign matter in the barrel.The following information was provided by the initial reporter: material no: 309578 batch no: unknown it was reported that graduation marks do not stick well and surface of barrel is waxy.
Additional Manufacturer Narrative
Investigation summary: 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.A device history record review could not be performed as lot number was unknown.

• Brand Name: BD LUER-LOK SYRINGE W/ PRECISIONGLIDE NEEDLE
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8728482
• Report Number: 1213809-2019-00646
• Device Sequence Number: 1729253
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• 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): 07/12/2019

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: 309578
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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