MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/BLUNT PLASTIC CANN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303346
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
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.Device manufacture date: unknown.
Event or Problem Description
It was reported that syringe 3ml ll w/blunt plastic can had foreign matter.The following information was provided by the initial reporter: material no: 303346, batch no: unknown.It was reported that the bd syringes with the blunt cannula are not working.They are drawing rubber from the top of the med vials into the syringes.
Event or Problem Description
It was reported that syringe 3ml ll w/blunt plastic cann had foreign matter.The following information was provided by the initial reporter: material no: 303346 batch no: unknown.It was reported that the bd syringes with the blunt cannula are not working.They are drawing rubber from the top of the med vials into the syringes.
Additional Manufacturer Narrative
H.6.Investigation: photos received displaying an image of a 3ml syringe.No defects observed.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: SYRINGE 3ML LL W/BLUNT PLASTIC CANN
• 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: 11593740
• Report Number: 1213809-2021-00184
• Device Sequence Number: 3511044
• Product Code: FMI
• UDI-Device Identifier: 00382903033461
• UDI-Public: 00382903033461
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 303346
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1