MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD TWINPAK; NEEDLE

Catalog Number	303393
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material# 303393 batch# 4114783 it was reported that the bd twinpak had a product packaging issue.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached hi xxx ¿ please see below comment from xxxx who purchases 303393.They noticed a change in packaging color and are having issues with inspection.We likely do not have a qa/cnc agreement with them and may not be obligated to notify nevertheless would be good to support them with some response on the change given the business we have been doing on a regular basis.They noted that the packaging of the material used to be clear but now has a green color.Item -303393 lot - 4114783 po- 4500273006.
Additional Manufacturer Narrative
(b)(4) supplemental mdr - packaging issue.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.However, this suggests the complaint is related to clear vs green colorant.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.

• Brand Name: BD TWINPAK
• Common Device Name: 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19908692
• Report Number: 1213809-2024-00519
• Device Sequence Number: 7079807
• Product Code: FMI
• UDI-Device Identifier: 00382903033935
• UDI-Public: (01)00382903033935
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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