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

Catalog Number	303393
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
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 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 bd twinpak¿ dual cannula device with syringe had excessive foreign matter in the sterile packaging.The following information was provided by the initial reporter: "excessive particulates inside of the sterile packages.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 27-feb-2023.H6: investigation summary five samples and ten photos were provided to our quality team for investigation.The other three samples were also visually inspected.It was observed that two samples had spots of embedded foreign matter on the needle shield.Lastly, the third sample was observed to have loose foreign matter inside the sterile package.The observed conditions were non-conforming per product specification.Potential root cause for embedded foreign defect is associated with the needle supplier¿s manufacturing process and loose foreign matter defect is related to the assembly process.As corrective action, overhead conveyor cleaning to assembly maintenance plan has been added.A device history record review was completed for provided lot number 1321729.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defects.H3 other text : see h10.
Event or Problem Description
It was reported that the bd twinpak¿ dual cannula device with syringe had excessive foreign matter in the sterile packaging.The following information was provided by the initial reporter: "excessive particulates inside of the sterile packages".

• Brand Name: BD TWINPAK¿ DUAL CANNULA DEVICE WITH 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16148431
• Report Number: 1213809-2023-00004
• Device Sequence Number: 6961452
• 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): 03/03/2023

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: 303393
• Device Lot Number: 1321729
• 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: 12/21/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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