MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE VIAL ACCESS ADAPTER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385108
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd q-syte vial access adapter expiration dates were labeled incorrectly the following information was provided by the initial reporter: it was reported by the customer that ensure if they are shipped locally the internal expiration date is checked on all product 2.At a minimum we need an ra from bd for the product we¿ve identified where the expiration on the individual packaging does not match the expiration on the box.Our fulfillment team found vial adapters ((b)(6) inventory id (b)(4) / mckesson # (b)(4) ) under lot # 3333847 with the expiration date of 10/31/2008, but the outer box has the expiration date of 10/31/2028.Under the same lot #, there is also product with the expiration date of 10/31/2028.Verbatim: rcc received a complaint via email.Ensure if they are shipped locally the internal expiration date is checked on all product 2.At a minimum we need an ra from bd for the product we¿ve identified where the expiration on the individual packaging does not match the expiration on the box.Our fulfillment team found vial adapters ((b)(6) inventory id (b)(4) / mckesson # (b)(4) ) under lot # 3333847 with the expiration date of 10/31/2008, but the outer box has the expiration date of 10/31/2028.Under the same lot #, there is also product with the expiration date of 10/31/2028.1.(b)(6) stocks this item at all of our locations.We will need to identify and return the incorrectly dated product for credit.2.For this lot number, can mckesson check the internal packaging to ensure all impacted product is pulled from the shelves? (b)(6).Dc number - 4 bill to number - (b)(4).Ship to number - (b)(4).Mms item number - 534015 (b)(6) branch item expirations received with need to quarantine and credit ¿ 325.
Additional Manufacturer Narrative
Our quality engineer inspected the 25 samples submitted for evaluation.The reported issue of documentation error was confirmed upon inspection of the samples.Analysis of the sample showed that the expiration date on the unit package does not match the expiration date printed on the dispenser.Bd determined that the cause of the failure was related to our manufacturing process.A quality alert was created, and all manufacturing personnel involved in the production of this product have been notified of the failure mode observed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
No new information.

• Brand Name: BD Q-SYTE VIAL ACCESS ADAPTER
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18960966
• Report Number: 9610847-2024-00065
• Device Sequence Number: 20669806
• Product Code: FPA
• UDI-Device Identifier: 00382903851089
• UDI-Public: (01)00382903851089
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K013621
• 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): 05/06/2024

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: 385108
• Device Lot Number: 3333847
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 05/06/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown