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

Model Number	367324
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fpa.Common device name: intravascular administration set.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that prior to use with bd vacutainer® push button blood collection set foreign matter was discovered in the tube.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, fm was found in the tubing before usage.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.4.Medical device lot #: 2131350, d.4.Medical device expiration date: 31-may-2024, d.10 device available for eval? yes, d.10 returned to manufacturer on: 3-apr-2023, h.2 device return to manuf.?: yes, h.4.Device manufacture date: 02-jun-2022.
Event or Problem Description
It was reported that prior to use with bd vacutainer® push button blood collection set foreign matter was discovered in the tube.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, fm was found in the tubing before usage.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received one sample and 6 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for unidentified material was observed.Additionally, the customer sample was evaluated by visual examination and material analysis and the indicated failure mode for unidentified material with the incident lot was observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode of unidentified material.The returned push button blood collection set (pbbcs) contained embedded material in the tubing that was determined to be clumps of tubing material that was likely introduced during extrusion.
Event or Problem Description
It was reported that prior to use with bd vacutainer® push button blood collection set foreign matter was discovered in the tube.The following information was provided by the initial reporter, translated from japanese to english: according to the customer's report, fm was found in the tubing before usage.

• 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 ; 8448235433
• MDR Report Key: 16675160
• Report Number: 1710034-2023-00358
• Device Sequence Number: 5219687
• Product Code: JKA
• UDI-Device Identifier: 50382903673242
• UDI-Public: (01)50382903673242
• 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,Followup
• Report Date (Section B): 06/01/2023

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: 05/31/2024
• Device Model Number: 367324
• Device Catalogue Number: 367324
• Device Lot Number: 2131350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 04/03/2023; 06/01/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 04/18/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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