MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD TWINPAK¿ DUAL CANNULA DEVICE WITH 3 ML SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303391
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd twinpak¿ dual cannula device with 3 ml syringe the needle broke.There was no report of patient impact.The following information was provided by the initial reporter: the customer reported broken found by a nurse.It was not used on a patient.It broke off.I cannot explain any further.Date of incident is (b)(6), 2023.
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.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 while using bd twinpak¿ dual cannula device with 3 ml syringe the needle broke.There was no report of patient impact.The following information was provided by the initial reporter: the customer reported broken found by a nurse.It was not used on a patient.It broke off.I cannot explain any further.Date of incident is aug.1, 2023.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 29-aug-2023 investigation summary one sample and two photos were provided to our quality team for investigation.Through visual inspection, it was observed that sample has a broken needle through needle hub.The condition observed is non-conforming per product specification.Potential root cause for the component damage defect is associated with the packaging process.This defect is occurring below an expected rate so no corrective actions will be made at this time.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.

• Brand Name: BD TWINPAK¿ DUAL CANNULA DEVICE WITH 3 ML SYRINGE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17599784
• Report Number: 1213809-2023-00891
• Device Sequence Number: 6712814
• Product Code: FMI
• UDI-Device Identifier: 30382903033912
• UDI-Public: (01)30382903033912
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: 303391
• Device Lot Number: 3137132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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