MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367323
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
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.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 failure of the product to contain blood or medication.This event occurred twice.The following information was provided by the initial reporter.The customer stated: customer reported a hole or cut in the tubing of item 367323 lot number 1075990.She stated when the needle was hooked up to the syringe, the blood would only make it to a certain spot in the tube and then drip out.The blood would not make it to the syringe because of the hole or cut.They have only noticed this on 2 of the tubes from this lot but she is having the staff look at the rest to see if there are more.The customer's blood had to be redrawn because of this.
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.This event occurred twice.The following information was provided by the initial reporter.The customer stated: customer reported a hole or cut in the tubing of item 367323 lot number 1075990.She stated when the needle was hooked up to the syringe, the blood would only make it to a certain spot in the tube and then drip out.The blood would not make it to the syringe because of the hole or cut.They have only noticed this on 2 of the tubes from this lot but she is having the staff look at the rest to see if there are more.The customer's blood had to be redrawn because of this.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/30/2021.H.6.Investigation: bd received 10 samples for investigation.The samples were evaluated by visually examination and functionally tested and the indicated failure mode for leakage with the incident lot was not observed as all product specifications were met.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.This complaint is unable to be confirmed for the indicated failure mode leakage.Bd was not able to identify a root cause for the indicated failure mode.

• 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: 12104288
• Report Number: 1710034-2021-00543
• Device Sequence Number: 11804663
• Product Code: JKA
• UDI-Device Identifier: 50382903673235
• UDI-Public: 50382903673235
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 08/17/2021

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: 03/31/2023
• Device Model Number: 367323
• Device Catalogue Number: 367323
• Device Lot Number: 1075990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1