MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER ACD SOLUTION B BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	364816
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0009484.Medical device expiration date: 2022-01-31.Device manufacture date: 2020-01-09.Medical device lot #: 0227127.Medical device expiration date: 2022-08-31.Device manufacture date: 2020-08-14.
Event or Problem Description
It was reported that 2 bd vacutainer® acd solution b blood collection tubes underfilled.The following information was provided by the initial reporter: "material no.364816, batch no.0009484 and 0227127.It is reported customer experienced under filling.Verbiage received, - "event description: while drawing labs on a patient the blood stop flowing.After trying several of the same type of vacutainers one finally worked.It was identified that the vacutainers had no vacuum in them"".
Event or Problem Description
It was reported that 2 bd vacutainer® acd solution b blood collection tubes underfilled.The following information was provided by the initial reporter: "material no.364816, batch no.0009484, and 0227127.It is reported customer experienced under filling.Verbiage received, - "event description: while drawing labs on a patient the blood stop flowing.After trying several of the same type of vacutainers one finally worked.It was identified that the vacutainers had no vacuum in them".
Additional Manufacturer Narrative
H.6.Investigation: bd received 2 contaminated samples from lot 0009484 and 15 unused samples from lot 0227127 for investigation.The contaminated samples could not be evaluated for the underfill defect.The 15 unused samples were evaluated by visual examination and 10 of them underwent draw testing and the indicated failure mode for underfill with the incident lot was not observed.Additionally, 10 retention samples for each lot number (0009484 and 0227127) from bd inventory were evaluated by visual examination and draw testing and no issues were observed relating to underfill 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.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER ACD SOLUTION B 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: 11657847
• Report Number: 1917413-2021-00291
• Device Sequence Number: 3495573
• Product Code: JKA
• UDI-Device Identifier: 50382903648165
• UDI-Public: 50382903648165
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 04/16/2021

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: 08/31/2022
• Device Model Number: 364816
• Device Catalogue Number: 364816
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1