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 (accredo inventory id 149037 / mckesson # 534015) 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.Email(s) attached 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 (accredo inventory id 149037 / mckesson # 534015) 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.Accredo 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? accredo branch city - memphis customer name e1 - accredo health group, inc - memphis dc number - 4 bill to number - 62084729 ship to number - 62084730 mms item number - (b)(4).Accredo branch item expirations received with need to quarantine and credit - 325.
Event or Problem Description
Ack send a follow up for additional questions: 1.Kindly provide the date of event.2.Can you share any physical sample or photo if available for investigation? if yes, please provide the address of the facility for us to ship the return label? 3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.1.2/28/2024 2.(b)(6).3.No patient impact.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of documentation error was confirmed upon inspection of the sample photo.Analysis of the sample photo showed that the expiration year on the unit packaging was different from the expiration year on the dispenser packaging.Bd determined that the cause of the failure was a result of our manufacturing process.The label information was incorrectly introduced into our printer machinery.A quality alert has been generated and all manufacturing personnel involved in the production of this product have been notified of the failure.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.

• 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: 18960965
• Report Number: 9610847-2024-00064
• Device Sequence Number: 7348985
• 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): 05/13/2024

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: 05/13/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 05/13/2024
• 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