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 Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: bd had not received samples, but 3 photos were provided by the customer for investigation.The photos were reviewed and the indicated failure mode for low draw volume with the incident lot was observed.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-conformance's during manufacturing of the product.Bd has initiated further root cause investigation relating to the issue of low draw volume through a corrective and preventive action.(capa) # (b)(4).
Event or Problem Description
It was reported that 4 bd vacutainer® acd solution b blood collection tubes had poor vacuum and underfilled during use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "received a call from the distributor stating that at four tubes will not suction.".

• 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: 10279178
• Report Number: 1917413-2020-00594
• Device Sequence Number: 13582212
• Product Code: JKA
• UDI-Device Identifier: 50382903648165
• UDI-Public: 50382903648165
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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: 08/31/2021
• Device Model Number: 364816
• Device Catalogue Number: 364816
• Device Lot Number: 9241949
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other