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	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.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.(b)(4).
Event or Problem Description
It was reported that prior to use the tubing was discovered to be sliced with a bd vacutainer push button blood collection set.The following information was provided by the initial reporter: it is reported customer received a wingset with severed tubing.
Additional Manufacturer Narrative
H.6.Investigation: received one (1) opened unit and one (1) customer photo.The customer photo shows the cut extension tubing on the device.The defect severed tubing was identified and confirmed with the returned unit the tubing being sliced in half from not being seated properly in the package blister of the bottom web.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 non-conformances during manufacturing of the product.
Event or Problem Description
It was reported that prior to use the tubing was discovered to be sliced with a bd vacutainer® push button blood collection set.The following information was provided by the initial reporter: it is reported customer received a wingset with severed 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
• MDR Report Key: 10414618
• Report Number: 1710034-2020-00516
• Device Sequence Number: 16610641
• 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
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: 367326
• Device Catalogue Number: 367326
• Device Lot Number: 9354891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other