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 Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
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.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for broken tube was observed.The brown substance visible in the photo is additive that has dried due to the tube breakage.A perforated stopper was not observed in the photo.Additionally, retention samples from bd inventory were evaluated by visual examination and no defects involving broken tubes, foreign matter, or stopper damage were observed.Bd was not able to determine a root cause for the tube breakage from the photo.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.
Event or Problem Description
It was reported when using the bd vacutainer® acd solution b blood collection tubes there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter: translated to english.The customer stated: "when opening the pack the tube was found with a foreign sediment in the bottom.".

• 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: 11441221
• Report Number: 1917413-2021-00164
• Device Sequence Number: 14250843
• Product Code: JKA
• UDI-Device Identifier: 50382903648165
• UDI-Public: 50382903648165
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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: 10/31/2021
• Device Model Number: 364816
• Device Catalogue Number: 364816
• Device Lot Number: 9280686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1