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	03/16/2021
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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: 1043495.It was reported that plastic rubber pieces are breaking off into the vial when syringes are being used.Verbatim: cath lab manager came to patient safety to notify of the above concern: a nurse in the cath lab stated she has noticed on almost every single fentanyl that plastic rubber pieces are breaking off into the vial when she uses the above syringes.Concerns voiced as these meds are sometimes given intra arterial and concerns of drawing up small plastic pieces.When this was voiced we pulled all bd syringes at washington hospital.Safe being placed by patient safety manager.
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: 1043495.It was reported that plastic rubber pieces are breaking off into the vial when syringes are being used.Verbatim: cath lab manager came to patient safety to notify of the above concern: a nurse in the cath lab stated she has noticed on almost every single fentanyl that plastic rubber pieces are breaking off into the vial when she uses the above syringes.Concerns voiced as these meds are sometimes given intra arterial and concerns of drawing up small plastic pieces.When this was voiced we pulled all bd syringes at washington hospital.Safe being placed by patient safety manager.
Additional Manufacturer Narrative
H.6.Investigation: two photos were received and evaluated.One photo displayed the top view of a package from batch 1043495 (p/n 303346).One photo displayed a medication vial with a small cylindrical foreign matter particle.The particle appeared to be a piece of the septum.It is possible the product was not used with the appropriate septum.Potential root cause for the foreign matter defect is likely associated with the customer misuse.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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: 11667827
• Report Number: 1213809-2021-00224
• Device Sequence Number: 3128462
• Product Code: FMI
• UDI-Device Identifier: 00382903033461
• UDI-Public: 00382903033461
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/15/2021

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 303346
• Device Lot Number: 1043495
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1