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	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set non patient needle separated from the holder.The following information was provided by the initial reporter: "material no.367326, batch no.0337059.It was reported that the needle shot out of the wingset.Per email: today (b)(6) 2021 i was drawing a patient as i went to end the draw and safety my needle.The needle shot out of the end and i was left holding the wing of the butterfly while the needle fell to the floor.No one was hurt or stuck.I took a picture of the butterfly and attached it.".
Additional Manufacturer Narrative
H6: investigation summary bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for needle separation with the incident lot was observed.Bd was unable to determine the root cause of the indicated failure mode was as the photo provided does not allow for an opportunity to perform a thorough investigation.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.
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set non patient needle separated from the holder.The following information was provided by the initial reporter: "material no.367326 batch no.0337059 it was reported that the needle shot out of the wingset.Per email: today (b)(6) 2021 i was drawing a patient as i went to end the draw and safety my needle.The needle shot out of the end and i was left holding the wing of the butterfly while the needle fell to the floor.No one was hurt or stuck.I took a picture of the butterfly and attached it.".

• 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
• MDR Report Key: 11510025
• Report Number: 1710034-2021-00204
• Device Sequence Number: 19653480
• Product Code: JKA
• UDI-Device Identifier: 50382903673266
• UDI-Public: 50382903673266
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 11/30/2022
• Device Model Number: 367326
• Device Catalogue Number: 367326
• Device Lot Number: 0337059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1