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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field there were multiple device types reported to be involved.The information for the additional device types are as follows medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set there were multiple device types reported to be involved.The information for the additional device types are as follows medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set 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, the device experienced cut tubing.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: the customer reported about cut tubing.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evalution?: yes.D9: returned to manufacturer on: 2022-10-12 h.6.Investigation summary: bd received 3 samples and 4 photos from the customer in support of this complaint.The customer samples and photos were evaluated, and the issue of cut tubing was observed.Additionally, 30 retain samples were subjected to a visual test for cut tubing.All of the samples passed exhibiting no cuts or damage to the tubing.Bd is able to confirm the customer¿s reported failure modes of cut tubing based on the customer samples and photo analysis; however, the issue was not observed in the retain testing.The 3 customer samples and photos, along with 100 retention samples from the bd inventory, were subjected to visual testing for preactivation and there was no issue observed relating to preactivation as all the samples passed testing exhibiting an iv needle that had not yet been activated.Bd is unable to confirm the customer¿s reported failure mode of preactivation based on the customer photo, sample and retain analysis.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set, the device experienced cut tubing.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: the customer reported about cut tubing.

• 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: 15492222
• Report Number: 1710034-2022-00552
• Device Sequence Number: 1793019
• 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): 11/07/2022

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: 05/31/2023
• Device Model Number: 367326
• Device Catalogue Number: 367326
• Device Lot Number: 1130321
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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