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

Model Number	366480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2020
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.(b)(4).
Event or Problem Description
It was reported the bd vacutainer® sodium heparin (nh) blood collection tubes experienced glass breakage during use.The following information was provided by the initial reporter.The customer experienced "glass breakage during centrifugation.Today we experience an issue with a bd vacutainer sodium heparin tube.A total of 4 of the same bd tubes were being centrifuged, 1/4 broke while in use.The centrifuge was properly balanced at time of use." additional information: customer stated they are spinning at 2000 rcf for 20 minutes.This is the procedure written in the study.It was explained that the maximum speed is 1300 rcf for 10 minutes, and that the excessive speed and time may have caused the tubes to break.Also recommended that their centrifuge be calibrated.There was no exposure, tests or medical interventions that were necessary.
Event or Problem Description
It was reported the bd vacutainer® sodium heparin (nh) blood collection tubes experienced glass breakage during use.The following information was provided by the initial reporter.The customer experienced "glass breakage during centrifugation.Today we experience an issue with a bd vacutainer sodium heparin tube.A total of 4 of the same bd tubes were being centrifuged, 1/4 broke while in use.The centrifuge was properly balanced at time of use." additional information: customer stated they are spinning at 2000 rcf for 20 minutes.This is the procedure written in the study.It was explained that the maximum speed is 1300 rcf for 10 minutes, and that the excessive speed and time may have caused the tubes to break.Also recommended that their centrifuge be calibrated.There was no exposure, tests or medical interventions that were necessary.
Additional Manufacturer Narrative
Investigation summary : bd had not received samples or photos from the customer for evaluation.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.Bd technical services provided troubleshooting to the customer.

• Brand Name: BD VACUTAINER SODIUM HEPARIN (NH) 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: 10960088
• Report Number: 1917413-2020-01216
• Device Sequence Number: 3186320
• Product Code: JKA
• UDI-Device Identifier: 50382903664806
• UDI-Public: 50382903664806
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 01/04/2021

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: 09/30/2021
• Device Model Number: 366480
• Device Catalogue Number: 366480
• Device Lot Number: 9260346
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1