MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 10ML SYRINGE WITH BD TWINPAK; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303393
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	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 bd 10ml syringe with bd twinpak had cloudy water in the fluid path issues.The following information was provided by the initial reporter : the customer reported to the genentech complaint management team of a cloudy swift in a 10-ml bd twinpak dual cannula device syringe.
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, a supplemental report will be filed.
Event or Problem Description
It was reported that 1 bd 10ml syringe with bd twinpak had cloudy water in the fluid path issues.The following information was provided by the initial reporter : the customer reported to the genentech complaint management team of a cloudy swfi in a 10-ml bd twinpak dual cannula device syringe.
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.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: BD 10ML SYRINGE WITH BD TWINPAK
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14496968
• Report Number: 1213809-2022-00302
• Device Sequence Number: 6150893
• Product Code: FMI
• UDI-Device Identifier: 00382903033935
• UDI-Public: 00382903033935
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2022

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: Lay User/Patient
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: 303393
• Device Lot Number: 9323515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown