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

Catalog Number	303346
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that an unspecified number of bd 3ml syringe with luer-lok¿ tip with blunt plastic cannulas experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.: 303346 batch no.: unknown.It was reported that when the nurse pierced the vial, a piece of the coring from the top of the vial was in the syringe.Verbatim: customer called in with issues regarding the # 3033496 3ml syringe.
Additional Manufacturer Narrative
Investigation summary: six photos were received and evaluated.Four photos displayed the medication vial from different angles.Two photos displayed a loose 3ml syringe with blunt cannula attached.It was observed there was approximately 1ml of clear fluid and a small red foreign matter particulate inside the syringe.The particle appeared to be a piece of the vial septum.No defects were confirmed with the returned product.It is possible the product was not used with the appropriate septum.Per product specification bd® syringe with blunt plastic cannula provides sterile needleless access into: vials designed for needleless access and pre-slit septum vial adapters for the withdrawal and measurement of fluids.Pre-slit septum iv systems for dispensing fluids.The reported defect was not identified in the photos received.A device history record review could not be performed as lot number was unknown.
Event or Problem Description
It was reported that an unspecified number of bd 3ml syringe with luer-lok¿ tip with blunt plastic cannulas experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.: 303346 ; batch no.: unknown.It was reported that when the nurse pierced the vial, a piece of the coring from the top of the vial was in the syringe.Verbatim: customer called in with issues regarding the # 3033496 3ml syringe.

• Brand Name: BD 3ML SYRINGE WITH LUER-LOK¿ TIP WITH BLUNT PLASTIC 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: 9292671
• Report Number: 1213809-2019-01119
• Device Sequence Number: 2245527
• Product Code: FMI
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 303346
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 11/07/2019
• Supplement Report FDA Received Date: 12/27/2019
• 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