MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367874
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ sodium heparinn (nh) 158 usp units blood collection tubes, the device experienced sample leakage.This event occurred four times.The following information was provided by the initial reporter.The customer stated: hello, we experienced whole blood leaking out of plastic sodium heparin tubes during air transport.What is the issue you experienced? 4 tubes from this lot were shipped in the same shipment and leaking of blood contents was seen after air transport.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for investigation.Therefore, one hundred (100) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to leakage as all samples met specifications.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 of leakage.Bd was not able to identify a root cause for the indicated failure mode.
Event or Problem Description
It was reported when using the bd vacutainer® sodium "heparin" (nh) 158 usp units blood collection tubes, the device experienced sample leakage.This event occurred four times.The following information was provided by the initial reporter.The customer stated: hello, we experienced whole blood leaking out of plastic sodium heparin tubes during air transport.What is the issue you experienced? 4 tubes from this lot were shipped in the same shipment and leaking of blood contents was seen after air transport.

• Brand Name: BD VACUTAINER SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 12277422
• Report Number: 1917413-2021-00702
• Device Sequence Number: 16922344
• Product Code: JKA
• UDI-Device Identifier: 50382903678742
• UDI-Public: 50382903678742
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K944566
• 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): 08/11/2021

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: 09/30/2022
• Device Model Number: 367874
• Device Catalogue Number: 367874
• Device Lot Number: 0258335
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1