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

Model 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	05/24/2022
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 927 bd twinpak¿ dual cannula devices with syringe had foreign, particulate matter found on them during the kitting process.The following information was provided by the initial reporter: "when kitting the bd syringes into our drug product packaging kit, the hto operations team performs a 100% visual inspection of the syringes.The team recently culled 927 particulate defects out of an inspected batch size of 12,900 units, which exceeded our internal defect action limit of 5%.Defect code: particulate inside of the sterile package defect rate: 7.2% (927 out of 12,900 units inspected)".
Additional Manufacturer Narrative
H6: investigation summary: 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.
Event or Problem Description
It was reported that 927 bd twinpak¿ dual cannula devices with syringe had foreign, particulate matter found on them during the kitting process.The following information was provided by the initial reporter: "when kitting the bd syringes into our drug product packaging kit, the hto operations team performs a 100% visual inspection of the syringes.The team recently culled 927 particulate defects out of an inspected batch size of 12,900 units, which exceeded our internal defect action limit of 5%.Defect code: particulate inside of the sterile package.Defect rate: 7.2% (927 out of 12,900 units inspected).".

• 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: 15080738
• Report Number: 1213809-2022-00409
• Device Sequence Number: 11965558
• Product Code: FMI
• UDI-Device Identifier: 30382903033936
• UDI-Public: 30382903033936
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: Other
• Device Expiration Date: 01/31/2026
• Device Model Number: 303393
• Device Catalogue Number: 303393
• Device Lot Number: 1040278
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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