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	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.Investigation summary: bd had not received samples or photos from the facility for evaluation.Additionally, we were unable to determine the specific lot number associated with this complaint.Therefore, a review of the manufacturing records could not be conducted.Bd is continually monitoring complaints received for this device and reported condition in order to identify emerging trends.
Event or Problem Description
It was reported that bd vacutainer® push button blood collection set non patient needle separated from the holder."material no.367326, batch no.Unknown.It is reported customer experienced needle separating verbiage received from pir submission, - "needle shot out the end of the wingset on to the floor while the butterfly was still in the hand of the clinician" (b)(6) 2021: pir states photo is available and that sample will be sent in but bd rep (b)(6) did not attach photo nor fill out facility's mailing address to send (b)(6) label.".
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for barrel separation with the incident lot was observed.Without the unit for investigation, it is difficult to identify a specific root cause as a thorough investigation of the components cannot be performed based on a photo.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."material no.367326, batch no.Unknown.It is reported customer experienced needle separating.Verbiage received from pir submission, - "needle shot out the end of the wingset on to the floor while the butterfly was still in the hand of the clinician." on 01-march-2021: pir states photo is available and that sample will be sent in but bd rep richard cooper did not attach photo nor fill out facility's mailing address to send fedex label.".

• 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: 11510026
• Report Number: 1710034-2021-00205
• Device Sequence Number: 3280786
• Product Code: JKA
• UDI-Device Identifier: 50382903673266
• UDI-Public: 50382903673266
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/21/2021

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 Model Number: 367326
• Device Catalogue Number: 367326
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1