MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305904
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	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the syringe 3ml ll w/ndl sftygld 25x5/8 rb experienced foreign matter along the fluid path.The following information was provided by the initial reporter: writer observed black flecks in the hub of the needle while opening a combo pack in preparation for vaccine injection.The combo pack had been freshly opened (previously sealed), and the needle piece had not been removed prior to noticing the black flecks, so they would have had to have been included prior to packaging.
Event or Problem Description
It was reported that the syringe 3ml ll w/ndl sftygld 25x5/8 rb experienced foreign matter along the fluid path.The following information was provided by the initial reporter: writer observed black flecks in the hub of the needle while opening a combo pack in preparation for vaccine injection.The combo pack had been freshly opened (previously sealed), and the needle piece had not been removed prior to noticing the black flecks, so they would have had to have been included prior to packaging.
Additional Manufacturer Narrative
H.6.Investigation: four photos were received and evaluated.Each photo showed a safetyglide needle with a visible black "fleck" of foreign matter inside the needle hub.The foreign matter was observed non-conforming per product specification.One sample received.Sample sent for fourier transform infrared spectroscopy (ftir) analysis.The foreign matter was determined to be polyetherimide via fourier transform infrared spectroscopy (ftir) analysis.Current production was evaluated to determine if there were any locations where this material could have come in contact with the product during packaging, with no relevant contact points or similar material found on the machine.Potential root cause of the polyetherimide could not be confirmed to have originated at the packaging plant (bd canaan) and manufacturing plant (bd columbus).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.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• 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: 12305643
• Report Number: 1213809-2021-00559
• Device Sequence Number: 14664605
• Product Code: FMI
• UDI-Device Identifier: 30382903059042
• UDI-Public: 30382903059042
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• 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): 09/23/2021

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: 10/31/2025
• Device Model Number: 305904
• Device Catalogue Number: 305904
• Device Lot Number: 0304974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1