MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367341
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
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.Investigation summary: bd received samples from the customer for investigation however, all samples were unable to be evaluated since the tubes were found to be past their expiration date of july 31.2020.Bd was unable to duplicate or confirm the customers indicated failure mode because the products had expired and does not recommend the use of expired products.A review of 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.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported when using the bd vacutainer¿ push button blood collection set, the device experienced failure of the product to contain blood or medication.The following information was provided by the initial reporter.The customer stated: pir verbiage received, - "blood leaving from hub.Appears cracked.".

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 11941290
• Report Number: 1024879-2021-00365
• Device Sequence Number: 4176230
• Product Code: JKA
• UDI-Device Identifier: 50382903673419
• UDI-Public: 50382903673419
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Report Date (Section B): 05/20/2021

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: 07/31/2020
• Device Model Number: 367341
• Device Catalogue Number: 367341
• Device Lot Number: 8190801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1