MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367326
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for each 510(k) number is as follows: common device name: intravascular administration set.Medical device type: fpa.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 when using the bd vacutainer® push button blood collection set there was incorrect label information.This event occurred 32 times.The following information was provided by the initial reporter.The customer stated: "when the barcode was scanned, 32 of 53 products (cat#367326) from lot#2021683 showed the expiration date displayed as 2024/01/30.It should be 2024/01/31.".
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set there was incorrect label information.This event occurred 32 times.The following information was provided by the initial reporter.The customer stated: "when the barcode was scanned, 32 of 53 products (cat#367326) from lot#2021683 showed the expiration date displayed as 2024/01/30.It should be 2024/01/31.".
Additional Manufacturer Narrative
H.6.Investigation summary: no customer samples or photos were received for review and analysis.As no customer samples or photos were received the scope of this investigation is limited.Therefore, 100 retention samples from the bd inventory were pulled and inspected for correct expiration date on the individual blister packages.All samples passed the testing as they had an expiration date that matched the shelf and case cartons.Therefore, this complaint cannot be confirmed based on retain sample testing results.Additionally, 2 shelf carton retains were inspected for correct expirations date.Both samples passed exhibiting the correct expiration date.Therefore, this complaint cannot be confirmed based on retain sample analysis.Bd is unable to confirm the customer¿s reported failure mode of incorrect/missing label information from the retain sample testing results.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Based on a review of batch records, customer sample analysis and retention sample results, no root cause from manufacturing was identified as a contributor.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.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15351253
• Report Number: 1710034-2022-00472
• Device Sequence Number: 17654573
• Product Code: JKA
• UDI-Device Identifier: 50382903673266
• UDI-Public: 50382903673266
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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: 01/31/2024
• Device Model Number: 367326
• Device Catalogue Number: 367326
• Device Lot Number: 2021683
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2022
• 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