MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305921
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	11/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.305921 batch no.Unknown.It was reported that the bd safetyglide¿ needle had an issue with foreign matter.There is a black substance in the barrel of the syringe.The following information was provided by the initial reporter: received voicemail from pharmacy manager stating, he is noticing "black substance" in the barrel of syringe.Stated, he discarded stated, only 1 syringe affected item: 305921.
Additional Manufacturer Narrative
Date of event: (b)(6) 2019.
Event or Problem Description
Material no.305921, batch no.Unknown.It was reported that the bd safetyglide¿ needle had an issue with foreign matter.There is a black substance in the barrel of the syringe.The following information was provided by the initial reporter: received voicemail from pharmacy manager stating, he is noticing "black substance" in the barrel of syringe.Stated, he discarded stated, only 1 syringe affected item: 305921.
Event or Problem Description
Material no.305921, batch no.Unknown.It was reported that the bd safetyglide¿ needle had an issue with foreign matter.There is a black substance in the barrel of the syringe.The following information was provided by the initial reporter: received voicemail from pharmacy manager stating, he is noticing "black substance" in the barrel of syringe.Stated, he discarded stated, only 1 syringe affected item: 305921.
Additional Manufacturer Narrative
H.6.Investigation: 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.H3 other text : see h.10.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• 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: 9437682
• Report Number: 1213809-2019-01233
• Device Sequence Number: 16837638
• Product Code: FMI
• UDI-Device Identifier: 30382903059219
• UDI-Public: 30382903059219
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2019

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: Health Professional
• Device Model Number: 305921
• Device Catalogue Number: 305921
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 11/18/2019; 11/18/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/12/2019; 12/18/2019
• 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