MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD TWINPAK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303393
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 303393 lot # 4114783 it was reported that the bd twinpak caps were not green in color.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached direct material name syringe, 10-ml bd twinpak dual cannula device vendor-batch-no 4114783 vendor-material-no 303393 defect missing green colorant in the bpc protection cap defect quantity entire bd batch ¿ a total of (b)(4) pcs country of origin usa on 22jul2024, during the bd syringe inspection at the site, the manufacturing inspection team observed that the syringe caps in bd batch 4114783 were in translucent white color, instead of translucent green color, per the purchasing specification xxx and per the bd product labeling on the syringes¿ sterile barrier system (sbs) follow-up: customer response on jul 31, 2024 sorry about the confusion on the defect description in the table in the request letter dated 24july2024.The correct description is missing the green colorant in the bpc protection cap.Please see the attached letter for the updated defect description in red.The picture of the defective cap and the other info you requested are in the investigation request letter.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Two photos of a 10ml twinpak syringe from batch 4114783 were provided to our quality team for investigation.One photo shows a portion of the top web package with product information included, and the other photo shows the needle with a red colored cap on one side and a clear colored cap on the other side.The condition observed is acceptable per specification deviation.Specification deviation was issued to manufacture the product with colorless caps.The product was evaluated to be acceptable for use.Marketing notifications were sent to impacted customers.
Event or Problem Description
No additional information was provided.

• Brand Name: BD TWINPAK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19990098
• Report Number: 1213809-2024-00545
• Device Sequence Number: 8460948
• Product Code: FMI
• UDI-Device Identifier: 00382903033935
• UDI-Public: (01)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
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: 4114783
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown